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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

713 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.

Results posted on

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

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

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

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

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 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 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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 27 deaths

Control Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 29 deaths

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

Phone: +46-(0)31-3421000

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place