Trial Outcomes & Findings for Prevention of Peritonitis in Peritoneal Dialysis (NCT NCT01293799)
NCT ID: NCT01293799
Last Updated: 2025-12-16
Results Overview
Time (days) after the date of randomization to the date of the first peritonitis episode was calculated for each participant. The cumulative time without peritonitis using the Cox regression model from which unadjusted hazard ratios were calculated. Actuarial survival curves showing proportions of peritonitis-free participants over time in the two groups were estimated by means of the Kaplan-Meier method. Log rank follow-up was used to compare the survival curves. Patients who stopped PD treatment due to causes other than peritonitis were managed according to the intention-to-treat principle.
COMPLETED
NA
713 participants
Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis, i.e. to maximally 35 months after randomization. Time to first peritonitis was calculated for each participant.
2025-12-16
Participant Flow
Recruitment started on January 18th, 2010 and ended on December 31st, 2014. The recruitment time was prolonged from planned two years to five years. Of the 713 initially included subjects, only 671 met the inclusion criteria. Of the 671 randomized subjects, 331 were assigned to the Control group and 340 to the Follow-up group.
Participant milestones
| Measure |
The Retraining Group
340 patients were allocated to the retraining group.
|
Control Group
331 subjects were allocated to the Control group.
|
|---|---|---|
|
Overall Study
STARTED
|
340
|
331
|
|
Overall Study
First Peritonitis Episode
|
102
|
121
|
|
Overall Study
COMPLETED
|
67
|
86
|
|
Overall Study
NOT COMPLETED
|
273
|
245
|
Reasons for withdrawal
| Measure |
The Retraining Group
340 patients were allocated to the retraining group.
|
Control Group
331 subjects were allocated to the Control group.
|
|---|---|---|
|
Overall Study
Kidney transplantation
|
109
|
96
|
|
Overall Study
Transfer to hemodialysis
|
70
|
90
|
|
Overall Study
Death
|
27
|
29
|
|
Overall Study
Transfer to assisted PD
|
24
|
18
|
|
Overall Study
Withdrawal by Subject
|
26
|
0
|
|
Overall Study
Investigator decision
|
5
|
2
|
|
Overall Study
Kidney function improved
|
6
|
7
|
|
Overall Study
Other causes
|
6
|
3
|
Baseline Characteristics
Data was missing for one subject in the Retraining group and 3 subjects in the Control group.
Baseline characteristics by cohort
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consisted of tests at the study visits of the patients´ theoretical and practical skills regarding peritoneal dialysis If the test goals were not passed, retraining was given until the goals were reached. The peritonitis rate in this group will be compared with that of the control group.
|
Control Group
n=331 Participants
Patients randomised to the control group were treated according to the routines of the clinic.
|
Total
n=671 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 Years
n=340 Participants
|
62 Years
n=331 Participants
|
62 Years
n=671 Participants
|
|
Sex: Female, Male
Female
|
111 Participants
n=340 Participants
|
114 Participants
n=331 Participants
|
225 Participants
n=671 Participants
|
|
Sex: Female, Male
Male
|
229 Participants
n=340 Participants
|
217 Participants
n=331 Participants
|
446 Participants
n=671 Participants
|
|
Region of Enrollment
Sweden
|
191 participants
n=340 Participants
|
192 participants
n=331 Participants
|
383 participants
n=671 Participants
|
|
Region of Enrollment
Latvia
|
25 participants
n=340 Participants
|
25 participants
n=331 Participants
|
50 participants
n=671 Participants
|
|
Region of Enrollment
Netherlands
|
25 participants
n=340 Participants
|
26 participants
n=331 Participants
|
51 participants
n=671 Participants
|
|
Region of Enrollment
Denmark
|
32 participants
n=340 Participants
|
27 participants
n=331 Participants
|
59 participants
n=671 Participants
|
|
Region of Enrollment
Estonia
|
11 participants
n=340 Participants
|
9 participants
n=331 Participants
|
20 participants
n=671 Participants
|
|
Region of Enrollment
Norway
|
30 participants
n=340 Participants
|
26 participants
n=331 Participants
|
56 participants
n=671 Participants
|
|
Region of Enrollment
Finland
|
22 participants
n=340 Participants
|
22 participants
n=331 Participants
|
44 participants
n=671 Participants
|
|
Region of Enrollment
United Kingdom
|
4 participants
n=340 Participants
|
4 participants
n=331 Participants
|
8 participants
n=671 Participants
|
|
Age 65 years or more
|
164 Participants
n=340 Participants
|
144 Participants
n=331 Participants
|
308 Participants
n=671 Participants
|
|
Body weight
|
77 Kg
STANDARD_DEVIATION 15 • n=340 Participants
|
79 Kg
STANDARD_DEVIATION 16 • n=331 Participants
|
78 Kg
STANDARD_DEVIATION 15 • n=671 Participants
|
|
Body mass index
|
26 Kg/m2
STANDARD_DEVIATION 4 • n=340 Participants
|
26 Kg/m2
STANDARD_DEVIATION 4 • n=331 Participants
|
26 Kg/m2
STANDARD_DEVIATION 4 • n=671 Participants
|
|
Primary cause of end-stage kidney disease
Diabetic nephropathy
|
63 Participants
n=340 Participants
|
87 Participants
n=331 Participants
|
150 Participants
n=671 Participants
|
|
Primary cause of end-stage kidney disease
Glomerulonephritis
|
87 Participants
n=340 Participants
|
87 Participants
n=331 Participants
|
174 Participants
n=671 Participants
|
|
Primary cause of end-stage kidney disease
Tubulointerstitial nephritis
|
17 Participants
n=340 Participants
|
17 Participants
n=331 Participants
|
34 Participants
n=671 Participants
|
|
Primary cause of end-stage kidney disease
Polycystic kidney disease
|
40 Participants
n=340 Participants
|
29 Participants
n=331 Participants
|
69 Participants
n=671 Participants
|
|
Primary cause of end-stage kidney disease
Ischemic kidney kisease
|
1 Participants
n=340 Participants
|
1 Participants
n=331 Participants
|
2 Participants
n=671 Participants
|
|
Primary cause of end-stage kidney disease
Nephrosclerosis/Hypertension
|
78 Participants
n=340 Participants
|
66 Participants
n=331 Participants
|
144 Participants
n=671 Participants
|
|
Primary cause of end-stage kidney disease
Other diagnosis
|
38 Participants
n=340 Participants
|
26 Participants
n=331 Participants
|
64 Participants
n=671 Participants
|
|
Primary cause of end-stage kidney disease
Unknown cause
|
16 Participants
n=340 Participants
|
18 Participants
n=331 Participants
|
34 Participants
n=671 Participants
|
|
Comorbidity
Ischemic heart disease
|
60 participants
n=340 Participants
|
62 participants
n=331 Participants
|
122 participants
n=671 Participants
|
|
Comorbidity
Peripheral vascular disease and stroke
|
39 participants
n=340 Participants
|
27 participants
n=331 Participants
|
66 participants
n=671 Participants
|
|
Comorbidity
Left ventricular dysfunction
|
37 participants
n=340 Participants
|
34 participants
n=331 Participants
|
71 participants
n=671 Participants
|
|
Comorbidity
Diabetes (comorbidity or main cause of kidney failure)
|
88 participants
n=340 Participants
|
111 participants
n=331 Participants
|
199 participants
n=671 Participants
|
|
Comorbidity
Collagen vascular disease
|
20 participants
n=340 Participants
|
10 participants
n=331 Participants
|
30 participants
n=671 Participants
|
|
Comorbidity
Other significant pathology
|
42 participants
n=340 Participants
|
30 participants
n=331 Participants
|
72 participants
n=671 Participants
|
|
Karnofsky performance scale for measurement of functional status
|
90 Score
n=340 Participants
|
90 Score
n=331 Participants
|
90 Score
n=671 Participants
|
|
Social factors
Visual impairment with reading problems
|
17 Participants
n=340 Participants
|
28 Participants
n=331 Participants
|
45 Participants
n=671 Participants
|
|
Social factors
Impaired hand function
|
23 Participants
n=340 Participants
|
21 Participants
n=331 Participants
|
44 Participants
n=671 Participants
|
|
Social factors
Working full or part time
|
103 Participants
n=340 Participants
|
102 Participants
n=331 Participants
|
205 Participants
n=671 Participants
|
|
Social factors
Retired
|
184 Participants
n=340 Participants
|
169 Participants
n=331 Participants
|
353 Participants
n=671 Participants
|
|
Social factors
Living alone
|
91 Participants
n=340 Participants
|
77 Participants
n=331 Participants
|
168 Participants
n=671 Participants
|
|
Social factors
Need for translation/interpreter
|
9 Participants
n=340 Participants
|
13 Participants
n=331 Participants
|
22 Participants
n=671 Participants
|
|
Social factors
Current smoking
|
34 Participants
n=340 Participants
|
39 Participants
n=331 Participants
|
73 Participants
n=671 Participants
|
|
Serum creatinine (at PD start)
|
640 Micromol/L
STANDARD_DEVIATION 234 • n=340 Participants
|
650 Micromol/L
STANDARD_DEVIATION 208 • n=331 Participants
|
645 Micromol/L
STANDARD_DEVIATION 222 • n=671 Participants
|
|
Serum urea (at PD start)
|
28 mmol/L
STANDARD_DEVIATION 9 • n=340 Participants
|
28 mmol/L
STANDARD_DEVIATION 9 • n=331 Participants
|
28 mmol/L
STANDARD_DEVIATION 9 • n=671 Participants
|
|
Serum albumin (at PD start)
|
34 g/L
STANDARD_DEVIATION 6 • n=339 Participants • Data was missing for one subject in the Retraining group and 3 subjects in the Control group.
|
34 g/L
STANDARD_DEVIATION 6 • n=328 Participants • Data was missing for one subject in the Retraining group and 3 subjects in the Control group.
|
34 g/L
STANDARD_DEVIATION 6 • n=667 Participants • Data was missing for one subject in the Retraining group and 3 subjects in the Control group.
|
|
Serum albumin < 35 g/L (at PD start)
|
169 Participants
n=339 Participants • Data was missing for one individual in the Retraining group and 3 individuals in the Control group.
|
169 Participants
n=328 Participants • Data was missing for one individual in the Retraining group and 3 individuals in the Control group.
|
338 Participants
n=667 Participants • Data was missing for one individual in the Retraining group and 3 individuals in the Control group.
|
|
Hemoglobin (at PD start)
|
110 mmol/L
STANDARD_DEVIATION 14 • n=339 Participants • Data was missing for one subject in the Retraining group.
|
111 mmol/L
STANDARD_DEVIATION 12 • n=331 Participants • Data was missing for one subject in the Retraining group.
|
111 mmol/L
STANDARD_DEVIATION 13 • n=670 Participants • Data was missing for one subject in the Retraining group.
|
|
C-reactive protein
|
3.0 g/L
n=338 Participants • Data was missing for 2 subjects in the Retraining group and 6 subjects in the Control group.
|
3.0 g/L
n=325 Participants • Data was missing for 2 subjects in the Retraining group and 6 subjects in the Control group.
|
3.0 g/L
n=663 Participants • Data was missing for 2 subjects in the Retraining group and 6 subjects in the Control group.
|
|
Medication
Corticosteroid drug
|
44 Participants
n=340 Participants
|
43 Participants
n=331 Participants
|
87 Participants
n=671 Participants
|
|
Medication
Other cytotoxic drug
|
27 Participants
n=340 Participants
|
25 Participants
n=331 Participants
|
52 Participants
n=671 Participants
|
|
Medication
No steroid or other cytotoxic drug medication
|
269 Participants
n=340 Participants
|
263 Participants
n=331 Participants
|
532 Participants
n=671 Participants
|
|
Participants from centers treating nasal carriers of S. aureus with nasal antibiotics
|
73 Participants
n=340 Participants
|
68 Participants
n=331 Participants
|
141 Participants
n=671 Participants
|
|
Participants from centers routinely using topical antibiotic cream on catheter exit site
|
38 Participants
n=340 Participants
|
34 Participants
n=331 Participants
|
72 Participants
n=671 Participants
|
|
Antibiotic prophylaxis before PD catheter insertion
|
305 Participants
n=340 Participants
|
305 Participants
n=331 Participants
|
610 Participants
n=671 Participants
|
|
Type of PD start
Planned
|
300 Participants
n=340 Participants
|
278 Participants
n=331 Participants
|
578 Participants
n=671 Participants
|
|
Type of PD start
Acute
|
40 Participants
n=340 Participants
|
53 Participants
n=331 Participants
|
93 Participants
n=671 Participants
|
|
PD catheter characteristics
Straight
|
78 Participants
n=340 Participants
|
76 Participants
n=331 Participants
|
154 Participants
n=671 Participants
|
|
PD catheter characteristics
Coiled
|
262 Participants
n=340 Participants
|
255 Participants
n=331 Participants
|
517 Participants
n=671 Participants
|
|
PD modality at PD start
CAPD
|
278 Participants
n=340 Participants
|
262 Participants
n=331 Participants
|
540 Participants
n=671 Participants
|
|
PD modality at PD start
APD
|
62 Participants
n=340 Participants
|
69 Participants
n=331 Participants
|
131 Participants
n=671 Participants
|
|
Help needed with exit-site care
|
79 Participants
n=340 Participants
|
84 Participants
n=331 Participants
|
163 Participants
n=671 Participants
|
PRIMARY outcome
Timeframe: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis, i.e. to maximally 35 months after randomization. Time to first peritonitis was calculated for each participant.Population: A number of 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. Participant who stopped PD treatment due to causes other than peritonitis were managed according to the intention-to-treat principle.
Time (days) after the date of randomization to the date of the first peritonitis episode was calculated for each participant. The cumulative time without peritonitis using the Cox regression model from which unadjusted hazard ratios were calculated. Actuarial survival curves showing proportions of peritonitis-free participants over time in the two groups were estimated by means of the Kaplan-Meier method. Log rank follow-up was used to compare the survival curves. Patients who stopped PD treatment due to causes other than peritonitis were managed according to the intention-to-treat principle.
Outcome measures
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=331 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Time to the First Dialysis-associated Peritonitis Episode in the Retraining Group and the Control Group
|
381 Days to first peritonitis episode
Interval 154.0 to 555.0
|
368 Days to first peritonitis episode
Interval 161.0 to 617.0
|
—
|
SECONDARY outcome
Timeframe: The participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis, i.e. to maximally 35 months after randomization. The time in study was calculated for each participantPopulation: 671 new patients with peritoneal dialysis, peritonitis-free, aged 18 year or more, and able to perform peritoneal dialysis without assistance were randomized to a control group or a follow-up group and followed up to 36 months after start of peritoneal dialysis. The time (patient-years) in the study to the first peritonitis episode was calculated for for each participant.
The incidence of a first peritonitis episode is expressed as the mean rate of a first peritonitis per patient year (event rate) with 95% confidence interval.
Outcome measures
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=331 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Incidence of a First Dialysis-associated Peritonitis Episode in the Control and the Retraining Group
|
0.29 Peritonitis events per patient-year
Interval 0.23 to 0.35
|
0.31 Peritonitis events per patient-year
Interval 0.26 to 0.37
|
—
|
SECONDARY outcome
Timeframe: The participants were followed from 1 month after PD start (time of randomization) up to 36 months after start of peritoneal dialysis, The time (days) of participation in the study was calculated for each participant.Population: 671 new patients with peritoneal dialysis, peritonitis-free, aged 18 year or more, and able to perform peritoneal dialysis without assistance were randomized to a control group or a follow-up group and followed up to 36 months after start of peritoneal dialysis.
The incidence of peritonitis episodes is expressed as the mean rate of peritonitis per patient year (event rate) with 95% confidence interval.
Outcome measures
| Measure |
The Retraining Group
n=331 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=340 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Incidence of All Peritonitis Episodes in the Control Group and the Retraining Group
|
0.36 Peritonitis event rate per patient year
Interval 0.31 to 0.41
|
0.33 Peritonitis event rate per patient year
Interval 0.28 to 0.39
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.
The association of baseline variables (at PD start) was studied in the whole study group. Age was recorded at baseline. Data were collected at baseline except for medication, PD modality (CAPD/APD, continuous ambulatory PD/automatic PD), number of PD bags and volume of dialysis fluid used per day, and if help with exit-site care was needed. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Outcome measures
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=331 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
n=671 Participants
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Analysis of Age in Association With Time to First Peritonitis Episode in the Whole Study Group
|
64 Age, years (See statistical analysis 1)
Interval 19.0 to 87.0
|
62 Age, years (See statistical analysis 1)
Interval 19.0 to 88.0
|
62 Age, years (See statistical analysis 1)
Interval 19.0 to 88.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.
Outcome data for the baseline variable "Gender" is presented. The association of baseline variables (at PD start) or time-updated variables with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Outcome measures
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=331 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
n=671 Participants
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Analysis of "Gender" in Association With Time to First Peritonitis Episode in the Whole Study Group
Male participants
|
229 Participants
|
217 Participants
|
446 Participants
|
|
Analysis of "Gender" in Association With Time to First Peritonitis Episode in the Whole Study Group
Female participants
|
111 Participants
|
114 Participants
|
225 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.
Outcome data for body weight at PD start is presented. The association of baseline variables (at PD start) or time-updated variables with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Outcome measures
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=331 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
n=671 Participants
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Analysis of "Body Weight" in Association With Time to First Peritonitis Episode in the Whole Study Group.
|
77 Kg
Standard Deviation 15
|
79 Kg
Standard Deviation 16
|
78 Kg
Standard Deviation 15
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis episode in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.
Outcome data for body mass index at PD start is presented. The association of baseline variables (at PD start) or time-updated variables with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Outcome measures
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=331 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
n=671 Participants
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Analysis of "Body Mass Index" in Association With Time to First Peritonitis Episode in the Whole Study Group.
|
26 Kg/m2
Standard Deviation 4
|
26 Kg/m2
Standard Deviation 4
|
26 Kg/m2
Standard Deviation 4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.
Outcome data for the baseline variable "Diabetic nephropathy" as primary cause of kidney failure are presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Outcome measures
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=331 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
n=671 Participants
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Analysis of "Diabetic Nephropathy" as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.
|
63 Participants
|
87 Participants
|
150 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.
Outcome data for the baseline variable "Glomerulonephritis" as primary cause of kidney failure is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Outcome measures
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=331 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
n=671 Participants
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Analysis of "Glomerulonephritis" as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.
|
87 Participants
|
87 Participants
|
174 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis episode in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.
Outcome data for the baseline variable "Tubulointerstitial nephritis" as primary cause of kidney failure is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Outcome measures
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=331 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
n=671 Participants
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Analysis of "Tubulointerstitial Nephritis" as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.
|
17 Participants
|
17 Participants
|
34 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.
Outcome data for the baseline variable "Polycystic kidney disease" as primary cause of kidney failure is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Outcome measures
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=331 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
n=671 Participants
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Analysis of "Polycystic Kidney Disease" as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.
|
40 Participants
|
29 Participants
|
69 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis episode in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.
Outcome data for the baseline variable "Ischemic kidney disease" as primary cause of kidney failure is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Outcome measures
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=331 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
n=671 Participants
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Analysis of "Ischemic Kidney Disease" as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.
|
1 Participants
|
1 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.
Outcome data for the baseline variable "Nephrosclerosis/hypertension" as primary cause of kidney failure is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Outcome measures
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=331 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
n=671 Participants
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Analysis of "Nephrosclerosis/Hypertension" as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.
|
78 Participants
|
66 Participants
|
144 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.
Outcome data for the baseline variable "Other diagnosis" as primary cause of kidney failure is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Outcome measures
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=331 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
n=671 Participants
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Analysis of "Other Diagnosis" as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.
|
38 Participants
|
26 Participants
|
64 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.
Outcome data for the baseline variable "Unknown primary cause of kidney failure" as primary cause of kidney failure are presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Outcome measures
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=331 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
n=671 Participants
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Analysis of "Unknown Primary Cause of Kidney Failure" in Association With Time to First Peritonitis Episode in the Whole Study Group.
|
16 Participants
|
18 Participants
|
34 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.
The statistical analysis of the baseline variable "Comorbidity" in association with time to first peritonitis episode is presented. The Stoke grading system of cardiovascular comorbidity was used to reflect the comorbid burden. Comorbidity was graded "0" when absent, "1" when 1 or 2, and "2" when 3 or more conditions were present. The association of baseline variables (at PD start) or time-updated variables with time to first was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Outcome measures
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=331 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
n=671 Participants
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Analysis of "Comorbidity" (According to Stoke Comorbidity Score) in Association With Time to First Peritonitis Episode in the Whole Study Group.
Stoke score 0 (No comorbidity)
|
193 Participants
|
202 Participants
|
395 Participants
|
|
Analysis of "Comorbidity" (According to Stoke Comorbidity Score) in Association With Time to First Peritonitis Episode in the Whole Study Group.
Stoke score 1-2 (1-2 comorbidities)
|
128 Participants
|
117 Participants
|
245 Participants
|
|
Analysis of "Comorbidity" (According to Stoke Comorbidity Score) in Association With Time to First Peritonitis Episode in the Whole Study Group.
Stoke Score > 2 (More than 2 comorbidities)
|
19 Participants
|
12 Participants
|
31 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.
The statistical analysis of the baseline variable "Ischemic heart disease" (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Outcome measures
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=331 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
n=671 Participants
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Analysis of "Ischemic Heart Disease" as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.
|
60 Participants
|
62 Participants
|
122 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.
The statistical analysis of the baseline variable "Peripheral vascular disease or stroke" (yes vs. no) in association with time to first peritonitis episode is presented. Peripheral vascular disease or stroke"" includes distal aortic, renovascular, and cerebrovascular disease as well as symptomatic disease in these vascular territories e.g. cerebrovascular accident, claudication, amputation or significant stenosis \>50% on vascular imaging or Doppler ultrasound. The association of baseline variables with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. The risk (hazard ratio) associated with each studied variable is reported.
Outcome measures
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=331 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
n=671 Participants
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Analysis of "Peripheral Vascular Disease or Stroke" as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.
|
39 Participants
|
27 Participants
|
66 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.
The statistical analysis of the baseline variable "Left ventricular dysfunction" (yes vs. no) in association with time to first peritonitis episode is presented. Left ventricular dysfunction includes clinical evidence of pulmonary oedema not attributable to errors in fluid balance or moderate to severe left ventricular dysfunction on echocardiography, or clinical signs of symptomatic moderate to severe heart failure. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Outcome measures
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=331 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
n=671 Participants
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Analysis of "Left Ventricular Dysfunction" as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.
|
37 Participants
|
34 Participants
|
71 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.
The statistical analysis of the baseline variable "Diabetes mellitus as comorbidity" (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Outcome measures
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=331 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
n=671 Participants
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Analysis of "Diabetes Mellitus as Comorbidity" in Association With Time to First Peritonitis Episode in the Whole Study Group.
|
25 Participants
|
24 Participants
|
49 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.
The statistical analysis of the baseline variable "System collagen vascular disease" (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Outcome measures
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=331 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
n=671 Participants
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Analysis of "System Collagen Vascular Disease" as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.
|
20 Participants
|
10 Participants
|
30 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.
The statistical analysis of the baseline variable "Other significant pathology" (yes vs. no) in association with time to first peritonitis episode is presented. Other significant pathology includes diseases like severe chronic obstructive airway disease, liver cirrhosis, psychotic illness, and severe osteoarthritis. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Outcome measures
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=331 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
n=671 Participants
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Analysis of "Other Significant Pathology" as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.
|
42 Participants
|
30 Participants
|
72 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.
The statistical analysis of the baseline variable "Diabetes mellitus as comorbidity or main cause of kidney failure" (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Outcome measures
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=331 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
n=671 Participants
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Analysis of "Diabetes Mellitus as Comorbidity or Main Cause of Kidney Failure" in Association With Time to First Peritonitis Episode in the Whole Study Group.
|
88 Participants
|
111 Participants
|
199 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.
The statistical analysis of the baseline variable "Previous kidney replacement therapy" (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Outcome measures
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=331 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
n=671 Participants
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Analysis of "Previous Kidney Replacement Therapy" in Association With Time to First Peritonitis Episode in the Whole Study Group.
|
68 Participants
|
61 Participants
|
129 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.
The statistical analysis of the baseline variable "Functional status (Karnofsky score)" in association with time to first peritonitis episode in the whole study group is presented. Functional status was estimated using the Karnofsky Performance Scale with scores from 100 (Normal, no complains, no evidence of disease) to 0 (dead). 90 = Able to carry on normal activity, minor signs or symptoms of disease. 80 = Normal activity with effort, some signs or symptoms of disease. 70 = Cares for self, unable to carry on normal activity or do active work. 60 = Requires occasional assistance, but able to to care for most of her/his needs. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. The risk (hazard ratio) associated with each studied variable is reported.
Outcome measures
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=331 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
n=671 Participants
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Analysis of "Functional Status (Karnofsky Score)" in Association With Time to First Peritonitis Episode in the Whole Study Group.
|
90 Karnofsky score numbers
Interval 80.0 to 95.0
|
90 Karnofsky score numbers
Interval 80.0 to 90.0
|
90 Karnofsky score numbers
Interval 80.0 to 90.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.
The statistical analysis of the baseline variable "Visual impairment" (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Outcome measures
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=331 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
n=671 Participants
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Analysis of the Social Factor "Visual Impairment" in Association With Time to First Peritonitis Episode in the Whole Study Group.
|
17 Participants
|
28 Participants
|
45 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.
The statistical analysis of the baseline social factor "Impaired hand function" (yes vs. no) in association with time to first peritonitis episode is presented. The impairment of hand function was unspecified. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Outcome measures
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=331 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
n=671 Participants
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Analysis of the Social Factor "Impaired Hand Function" in Association With Time to First Peritonitis Episode in the Whole Study Group.
|
23 Participants
|
21 Participants
|
44 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.
The statistical analysis of the baseline social factor "Working full or part time" (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Outcome measures
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=331 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
n=671 Participants
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Analysis of the Social Factor "Working Full or Part Time" in Association With Time to First Peritonitis Episode in the Whole Study Group.
|
103 Participants
|
102 Participants
|
205 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.
The statistical analysis of the baseline social factor "Retired" (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Outcome measures
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=331 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
n=671 Participants
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Analysis of the Social Factor "Retired" in Association With Time to First Peritonitis Episode in the Whole Study Group.
|
184 Participants
|
169 Participants
|
353 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.
The statistical analysis of the baseline social factor "Living alone" (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.
Outcome measures
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=331 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
n=671 Participants
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Analysis of the Social Factor "Living Alone" in Association With Time to First Peritonitis Episode in the Whole Study Group.
|
91 Participants
|
77 Participants
|
168 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.
The statistical analysis of the baseline social factor "Working full or part time" (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.
Outcome measures
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=331 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
n=671 Participants
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Analysis of the Social Factor "Need for Translation/Interpreter" in Association With Time to First Peritonitis Episode in the Whole Study Group.
|
9 Participants
|
13 Participants
|
22 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.
The statistical analysis of the baseline social factor "Current smoking" (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.
Outcome measures
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=331 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
n=671 Participants
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Analysis of the Social Factor "Current Smoking" in Association With Time to First Peritonitis Episode in the Whole Study Group.
|
34 Participants
|
39 Participants
|
73 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.
The statistical analysis of the baseline biological characteristic Serum creatinine (micromol/L) in association with time to first peritonitis episode is presented. Serum creatinine was measured just before the start of peritoneal dialysis. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.
Outcome measures
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=331 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
n=671 Participants
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Analysis of the Biochemical Characteristic "Serum Creatinine" in Association With Time to First Peritonitis Episode in the Whole Study Group.
|
640 Micromol/L
Standard Deviation 234
|
650 Micromol/L
Standard Deviation 208
|
645 Micromol/L
Standard Deviation 222
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.
The statistical analysis of the baseline biological characteristic Serum urea (mmol/L) in association with time to first peritonitis episode is presented. Serum urea was measured just before the start of peritoneal dialysis. The association of baseline variables (at PD start) with time to first peritonitis episode was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.
Outcome measures
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=331 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
n=671 Participants
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Analysis of the Biochemical Characteristic "Serum Urea" in Association With Time to First Peritonitis Episode in the Whole Study Group.
|
28 mmol/L
Standard Deviation 9
|
28 mmol/L
Standard Deviation 9
|
28 mmol/L
Standard Deviation 9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.
The statistical analysis of the baseline biological characteristic" Serum albumin" (g/L) in association with time to first peritonitis episode is presented. Serum albumin was measured just before the start of peritoneal dialysis. The association of baseline variables (at PD start) with time to first peritonitis episode was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.
Outcome measures
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=331 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
n=671 Participants
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Analysis of the Biochemical Characteristic "Serum Albumin" in Association With Time to First Peritonitis Episode in the Whole Study Group.
|
34 g/L
Standard Deviation 6
|
34 g/L
Standard Deviation 6
|
34 g/L
Standard Deviation 6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.
The statistical analysis of the baseline biological characteristic "Serum albumin" (\< 35 g/L vs. 35 g/L or more) in association with time to first peritonitis episode is presented. Serum albumin was measured just before the start of peritoneal dialysis. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.
Outcome measures
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=331 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
n=671 Participants
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Analysis of the Biochemical Characteristic "Serum Albumin (< 35 g/L vs. 35 g/L or More)" in Association With Time to First Peritonitis Episode in the Whole Study Group.
Serum albumin <35 g/L
|
169 Participants
|
169 Participants
|
338 Participants
|
|
Analysis of the Biochemical Characteristic "Serum Albumin (< 35 g/L vs. 35 g/L or More)" in Association With Time to First Peritonitis Episode in the Whole Study Group.
Serum albumin 35 g/L or more
|
171 Participants
|
162 Participants
|
333 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.
The statistical analysis of the baseline biological characteristic "Serum haemoglobin" (mmol/L) in association with time to first peritonitis episode is presented. Serum haemoglobin was measured just before the start of peritoneal dialysis. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.
Outcome measures
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=331 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
n=671 Participants
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Analysis of the Biochemical Characteristic "Haemoglobin" in Association With Time to First Peritonitis Episode in the Whole Study Group.
|
110 mmol/L
Standard Deviation 14
|
111 mmol/L
Standard Deviation 12
|
111 mmol/L
Standard Deviation 13
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.
The analysis of the use of a "Corticosteroid drug" (yes vs.no) in association with time to first peritonitis episode is presented. This variable may vary with time and is thus time-dependent. The variable was recorded at all study visits. The value recorded at the study visit which was closest to and prior to the first peritonitis episode was used in the univariable and multivariable Cox regression analyses of the association of the variable with time to first peritonitis episode. Time-dependent univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The count of participants on corticosteroid treatment at baseline is presented below.
Outcome measures
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=331 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
n=671 Participants
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Analysis of the Use of a "Corticosteroid Drug" in Association With Time to First Peritonitis Episode in the Whole Study Group.
|
44 Participants
|
43 Participants
|
87 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.
Analysis of "Cytotoxic treatment" (yes vs.no) in association with time to first peritonitis episode is presented. This variable may vary with time and is thus time-dependent. The variable was recorded at all study visits. The value recorded at the study visit which was closest to and prior to the first peritonitis episode was used in the time-dependent univariable and multivariable Cox regression analyses of the association of the variable with time to first peritonitis episode. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The count of participants on cytotoxic treatment at baseline is presented below.
Outcome measures
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=331 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
n=671 Participants
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Analysis of "Cytotoxic Treatment" in Association With Time to First Peritonitis Episode in the Whole Study Group.
|
27 Participants
|
25 Participants
|
52 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.
The statistical analysis of "Type of start of peritoneal dialysis" in association with time to first peritonitis episode is presented. The type of start of peritoneal dialysis could be either planned or acute. The association of "Type of start of peritoneal dialysis" in association with time to first peritonitis episode was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.
Outcome measures
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=331 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
n=671 Participants
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Analysis of "Type of Start of Peritoneal Dialysis" in Association With Time to First Peritonitis Episode in the Whole Study Group.
Planned PD start
|
300 Participants
|
278 Participants
|
578 Participants
|
|
Analysis of "Type of Start of Peritoneal Dialysis" in Association With Time to First Peritonitis Episode in the Whole Study Group.
Acute PD start
|
40 Participants
|
53 Participants
|
93 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis episode in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.
The statistical analysis of "The use of antibiotics prior to PD catheter insertion" (yes vs. no) in association with time to first peritonitis episode is presented. Antibiotics prior to PD catheter insertion may be given to prevent infection. The association of "The use of antibiotics prior to PD catheter insertion" in association with time to first peritonitis episode was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The count of participants who used antibiotics prior to PD catheter insertion is presented below.
Outcome measures
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=331 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
n=671 Participants
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Analysis of "The Use of Antibiotics Prior to PD Catheter Insertion" in Association With Time to First Peritonitis Episode in the Whole Study Group.
|
305 Participants
|
305 Participants
|
610 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.
PD catheters could be either be straight or coiled. The statistical analysis of "the type of PD catheter used" (straight vs. coiled) in association with time to first peritonitis episode is presented. The association of "the type of PD catheter used" in association with time to first peritonitis episode was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.
Outcome measures
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=331 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
n=671 Participants
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Analysis of "the Type of PD Catheter Used" in Association With Time to First Peritonitis Episode in the Whole Study Group.
Straight PD catheter
|
78 Participants
|
76 Participants
|
154 Participants
|
|
Analysis of "the Type of PD Catheter Used" in Association With Time to First Peritonitis Episode in the Whole Study Group.
Coiled PD catheter
|
262 Participants
|
255 Participants
|
517 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.
"PD modality (CAPD/APD)" in Association With Time to First Peritonitis Episode in the whole study group was studied. A participant either used CAPD (Continuous Ambulatory Peritoneal Dialysis) or APD (Automated Peritoneal Dialysis) but may change the PD modality during the study. This variable may vary with time and is thus time-dependent. The time-dependent data was recorded at all study visits. The value recorded at the study visit which was closest to and prior to the first peritonitis episode for each participant was used in the analyses. The time-dependent data was included in a time-dependent Cox regression. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The c
Outcome measures
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=331 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
n=671 Participants
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Analysis of "PD Modality (CAPD/APD)" in Association With Time to First Peritonitis Episode in the Whole Study Group.
CAPD at PD start
|
278 Participants
|
262 Participants
|
540 Participants
|
|
Analysis of "PD Modality (CAPD/APD)" in Association With Time to First Peritonitis Episode in the Whole Study Group.
APD at PD start
|
62 Participants
|
69 Participants
|
131 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.
The association of the "Number of PD bags used/24h" and Time to First Peritonitis Episode was studied. The number of PD bags used/24h many vary with time, as this variable is thus time-dependent. Data from PD start is presented below. As described in "Outcome measure 39", data was collected at each study visit. We recorded the number of bags connected to the PD catheter/24h in CAPD patients and in APD patients we recorded the number of bags connected to the tubing set/24h adding the daily number of bags connected to the PD catheter if additional manual daytime exchanges were used. The time-dependent data was included in a time-dependent univariable Cox regression to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.
Outcome measures
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=331 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
n=671 Participants
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Analysis of "Number of PD Bags Used/24h" in Association With of Time to First Peritonitis Episode in the Whole Study Group.
|
4 Number of PD bags/24h at PD start
Interval 1.0 to 5.0
|
4 Number of PD bags/24h at PD start
Interval 1.0 to 6.0
|
4. Number of PD bags/24h at PD start
Interval 1.0 to 6.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.
The association of "The Volume of Dialysis Fluid used/24h" with the time to first peritonitis episode is analysed in the whole study group. The volume of dialysis fluid used per 24h can vary with time and is thus time-dependent. The dialysis fluid volume/24h used at PD start is reported below. The time-dependent data were recorded at all study visits. The value recorded at the study visit, which was closest to and prior to the first peritonitis episode for each participant was used in the analyses. The time-dependent data were included in a time-dependent Cox regression. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.
Outcome measures
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=331 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
n=671 Participants
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Analysis of "The Volume of Dialysis Fluid Used/24h" in Association With Time to First Peritonitis Episode in the Whole Study Group.
|
8.0 Liter of PD fluid used/24h at PD start
Interval 1.5 to 18.5
|
8.0 Liter of PD fluid used/24h at PD start
Interval 1.5 to 22.0
|
8.0 Liter of PD fluid used/24h at PD start
Interval 1.5 to 22.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.
The exit site is the point where the PD catheter emerges from the skin of the abdomen. The number of "participants who needed of help with exit-site care at PD start is reported below. The need of this help may vary with time. This variable is thus time-dependent. The time-dependent data were recorded at all study visits. The value recorded at the study visit, which was closest to and prior to the first peritonitis episode for each participant was used in the analyses. The data were included as time-varying covariates in a time-dependent Cox regression. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Outcome measures
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=331 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
n=671 Participants
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Analysis of "Need of Help With Exit-site Care" in Association With Time to First Peritonitis Episode in the Whole Study Group.
|
84 Participants
|
79 Participants
|
163 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group.
Analysis of the association of the Study group (retraining group vs. control group) with time to first peritonitis episode is presented. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Outcome measures
| Measure |
The Retraining Group
n=340 Participants
The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.
|
The Control Group
n=331 Participants
Patients randomised to the control group will be treated according to the routines of the clinic.
|
The Whole Study Group
n=671 Participants
The Retraining Group and The Control Group together.
|
|---|---|---|---|
|
Analysis of the Association of the Study Group (Retraining Group vs. the Control Group) With Time to First Peritonitis Episode
|
340 Participants
|
331 Participants
|
671 Participants
|
Adverse Events
The Follow-up Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Susanne Ljungman prof. emer. Director of the study
Dept. of Nephrology, Sahlgrenska University Hospital, Gothenburg, Sweden
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place