Trial Outcomes & Findings for Ultrafiltration Profiling and Outcomes Among Individuals on Maintenance Hemodialysis (NCT NCT03301740)
NCT ID: NCT03301740
Last Updated: 2020-05-15
Results Overview
Intradialytic blood pressure (BP) was measured with an upper extremity cuff in seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols. Intradialytic hypotension was defined as the presence of a nadir systolic BP \<90 mmHg. Odds ratios were estimated using a mixed model (repeated measures logistic regression model).
COMPLETED
NA
34 participants
Every study hemodialysis treatment, up to 36 treatments per participant over 15 weeks
2020-05-15
Participant Flow
Participant milestones
| Measure |
UF Profiling Phase First
First treatment phase begins with linear UF profiling during HD.
Participants randomized to starting with the experimental UF profiling phase will receive 9 HD treatments with UF profiling (1st experimental phase). Following a 3 conventional HD treatment wash-out period, participants will then cross over to 9 conventional HD treatments (1st control phase). Following a 2nd 3 conventional HD treatment wash-out period, participants will cross over to 9 HD treatments with UF profiling (2nd experimental phase). Following a 3rd conventional HD treatment wash-out period, participants will cross over to 9 conventional HD treatments (2nd control phase).
|
Conventional HD Phase First
First treatment phase begins with conventional HD.
Participants randomized to starting with the control conventional HD phase will receive 9 conventional HD treatments (1st control phase). Following a 3 conventional HD treatment wash-out period, participants will then cross over to 9 HD treatments with UF profiling (1st experimental phase). Following a 2nd 3 conventional HD treatment wash-out period, participants will cross over to 9 conventional HD treatments (2nd control phase). Following a 3rd conventional HD treatment wash-out period, participants will cross over to 9 HD treatments with UF profiling (2nd experimental phase).
|
|---|---|---|
|
Phase 1 Intervention (3 Weeks)
STARTED
|
18
|
16
|
|
Phase 1 Intervention (3 Weeks)
COMPLETED
|
18
|
16
|
|
Phase 1 Intervention (3 Weeks)
NOT COMPLETED
|
0
|
0
|
|
First Washout (1 Week)
STARTED
|
18
|
16
|
|
First Washout (1 Week)
COMPLETED
|
18
|
16
|
|
First Washout (1 Week)
NOT COMPLETED
|
0
|
0
|
|
Phase 2 Intervention (3 Weeks)
STARTED
|
18
|
16
|
|
Phase 2 Intervention (3 Weeks)
COMPLETED
|
17
|
16
|
|
Phase 2 Intervention (3 Weeks)
NOT COMPLETED
|
1
|
0
|
|
Second Washout (1 Week)
STARTED
|
17
|
16
|
|
Second Washout (1 Week)
COMPLETED
|
17
|
16
|
|
Second Washout (1 Week)
NOT COMPLETED
|
0
|
0
|
|
Phase 3 Intervention (3 Weeks)
STARTED
|
17
|
16
|
|
Phase 3 Intervention (3 Weeks)
COMPLETED
|
17
|
16
|
|
Phase 3 Intervention (3 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Third Washout (1 Week)
STARTED
|
17
|
16
|
|
Third Washout (1 Week)
COMPLETED
|
17
|
16
|
|
Third Washout (1 Week)
NOT COMPLETED
|
0
|
0
|
|
Phase 4 Intervention (3 Weeks)
STARTED
|
17
|
16
|
|
Phase 4 Intervention (3 Weeks)
COMPLETED
|
16
|
16
|
|
Phase 4 Intervention (3 Weeks)
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
UF Profiling Phase First
First treatment phase begins with linear UF profiling during HD.
Participants randomized to starting with the experimental UF profiling phase will receive 9 HD treatments with UF profiling (1st experimental phase). Following a 3 conventional HD treatment wash-out period, participants will then cross over to 9 conventional HD treatments (1st control phase). Following a 2nd 3 conventional HD treatment wash-out period, participants will cross over to 9 HD treatments with UF profiling (2nd experimental phase). Following a 3rd conventional HD treatment wash-out period, participants will cross over to 9 conventional HD treatments (2nd control phase).
|
Conventional HD Phase First
First treatment phase begins with conventional HD.
Participants randomized to starting with the control conventional HD phase will receive 9 conventional HD treatments (1st control phase). Following a 3 conventional HD treatment wash-out period, participants will then cross over to 9 HD treatments with UF profiling (1st experimental phase). Following a 2nd 3 conventional HD treatment wash-out period, participants will cross over to 9 conventional HD treatments (2nd control phase). Following a 3rd conventional HD treatment wash-out period, participants will cross over to 9 HD treatments with UF profiling (2nd experimental phase).
|
|---|---|---|
|
Phase 2 Intervention (3 Weeks)
Kidney Transplant
|
1
|
0
|
|
Phase 4 Intervention (3 Weeks)
Prolonged Hospitalization
|
1
|
0
|
Baseline Characteristics
Ultrafiltration Profiling and Outcomes Among Individuals on Maintenance Hemodialysis
Baseline characteristics by cohort
| Measure |
UF Profiling Phase First
n=18 Participants
First treatment phase begins with linear UF profiling during HD.
Participants randomized to starting with the experimental UF profiling phase will receive 9 HD treatments with UF profiling (1st experimental phase). Following a 3 conventional HD treatment wash-out period, participants will then cross over to 9 conventional HD treatments (1st control phase). Following a 2nd 3 conventional HD treatment wash-out period, participants will cross over to 9 HD treatments with UF profiling (2nd experimental phase). Following a 3rd conventional HD treatment wash-out period, participants will cross over to 9 conventional HD treatments (2nd control phase).
|
Conventional HD Phase First
n=16 Participants
First treatment phase begins with conventional HD.
Participants randomized to starting with the control conventional HD phase will receive 9 conventional HD treatments (1st control phase). Following a 3 conventional HD treatment wash-out period, participants will then cross over to 9 HD treatments with UF profiling (1st experimental phase). Following a 2nd 3 conventional HD treatment wash-out period, participants will cross over to 9 conventional HD treatments (2nd control phase). Following a 3rd conventional HD treatment wash-out period, participants will cross over to 9 HD treatments with UF profiling (2nd experimental phase).
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55 Years
STANDARD_DEVIATION 15 • n=5 Participants
|
57 Years
STANDARD_DEVIATION 15 • n=7 Participants
|
56 Years
STANDARD_DEVIATION 15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every study hemodialysis treatment, up to 36 treatments per participant over 15 weeksPopulation: All participants who completed at least one phase of each study arm.
Intradialytic blood pressure (BP) was measured with an upper extremity cuff in seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols. Intradialytic hypotension was defined as the presence of a nadir systolic BP \<90 mmHg. Odds ratios were estimated using a mixed model (repeated measures logistic regression model).
Outcome measures
| Measure |
UF Profiling
n=33 Participants
Linear UF profiling (linearly decreasing UF rate with a UF rate starting at 1.33 times the rate that would be needed at a constant UF rate to achieve the desired post-weight; preprogrammed "profile 2" on a Fresenius 2008K machine). Ultrafiltration profiling performed using Fresenius 2008K dialysis machines in accordance with manufacturer instructions.
|
Conventional HD
n=33 Participants
Conventional HD (routine care) is the participant's standard HD prescription without UF profiling
|
|---|---|---|
|
Occurrence of Intradialytic Hypotension (Intradialytic Hypotension Defined as Nadir Systolic BP <90 mmHg)
|
578 Number of occurrences
|
571 Number of occurrences
|
PRIMARY outcome
Timeframe: Weeks 3, 7, 11, and 15Population: All participants who completed at least one phase of each study arm.
Troponin T blood samples were collected at 4 study visits. Specifically, at the 7th hemodialysis treatment in each respective study phase (i.e., at week 3, 7, 11, and 15 study visits). Pre- to post-hemodialysis troponin T change was calculated as: post-dialysis troponin T - pre-dialysis troponin T (ng/mL). A lower change value reflects less cardiac strain. Based on the pre-specified protocol, the reported values represent change in troponin T between pre- and post-hemodialysis using mixed model (repeated measures logistic regression) analysis that considered all specified time-points (i.e., weeks 3, 7, 11, and 15).
Outcome measures
| Measure |
UF Profiling
n=33 Participants
Linear UF profiling (linearly decreasing UF rate with a UF rate starting at 1.33 times the rate that would be needed at a constant UF rate to achieve the desired post-weight; preprogrammed "profile 2" on a Fresenius 2008K machine). Ultrafiltration profiling performed using Fresenius 2008K dialysis machines in accordance with manufacturer instructions.
|
Conventional HD
n=33 Participants
Conventional HD (routine care) is the participant's standard HD prescription without UF profiling
|
|---|---|---|
|
Pre- to Post-hemodialysis Treatment Change in Troponin T Level in ng/mL at Weeks 3, 7, 11, and 15, Using Mixed Model Analysis
|
12.3 ng/mL
Interval 4.4 to 20.2
|
11.3 ng/mL
Interval 3.4 to 19.2
|
PRIMARY outcome
Timeframe: Weeks 3, 7, 11, and 15Population: All participants who completed at least one phase of each study arm.
Troponin T blood samples were collected before and after each participant's 7th hemodialysis treatment of each study phase (4 times during the study). Troponin T percentage change was calculated as \[(Post-HD troponin T - pre-HD troponin T) / pre-HD troponin T\] x100. Troponin T percentage rise was defined as a troponin T percentage change ≥10%. Odds ratios were estimated using a mixed model (repeated measures logistic regression model).
Outcome measures
| Measure |
UF Profiling
n=33 Participants
Linear UF profiling (linearly decreasing UF rate with a UF rate starting at 1.33 times the rate that would be needed at a constant UF rate to achieve the desired post-weight; preprogrammed "profile 2" on a Fresenius 2008K machine). Ultrafiltration profiling performed using Fresenius 2008K dialysis machines in accordance with manufacturer instructions.
|
Conventional HD
n=33 Participants
Conventional HD (routine care) is the participant's standard HD prescription without UF profiling
|
|---|---|---|
|
Occurrence of a ≥10% Troponin T Percentage Rise From Pre- to Post-hemodialysis Treatment
|
64 Number of occurrences
|
63 Number of occurrences
|
PRIMARY outcome
Timeframe: Weeks 3 and 7Population: All participants who had baseline GLS measurement and had one GLS measurement in each study arm.
Left ventricular GLS was measured with transthoracic echocardiography at baseline and at 30 minutes before HD treatment end during the 7th treatment in the first phase of each arm. Left ventricular GLS change was calculated as peak intradialytic stress GLS - baseline GLS (%). A lower change value reflects lesser cardiac strain. Median differences were estimated using Wilcoxon (Mann-Whitney) tests.
Outcome measures
| Measure |
UF Profiling
n=29 Participants
Linear UF profiling (linearly decreasing UF rate with a UF rate starting at 1.33 times the rate that would be needed at a constant UF rate to achieve the desired post-weight; preprogrammed "profile 2" on a Fresenius 2008K machine). Ultrafiltration profiling performed using Fresenius 2008K dialysis machines in accordance with manufacturer instructions.
|
Conventional HD
n=27 Participants
Conventional HD (routine care) is the participant's standard HD prescription without UF profiling
|
|---|---|---|
|
Change From Baseline in Percent Left Ventricular Global Longitudinal Strain (GLS)
|
0.9 GLS change (%)
Interval -0.1 to 1.8
|
1.3 GLS change (%)
Interval 0.1 to 2.4
|
SECONDARY outcome
Timeframe: Every study hemodialysis treatment, up to 36 treatments per participant over 15 weeksPopulation: All participants who completed at least one phase of each study arm.
Intradialytic BP was measured with an upper extremity cuff in seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols. Nadir systolic BP was defined as the lowest intradialytic systolic BP measurement during each hemodialysis treatment. Lower values reflect greater cardiac strain. Beta-coefficients were estimated using a mixed model (repeated measures linear regression model).
Outcome measures
| Measure |
UF Profiling
n=33 Participants
Linear UF profiling (linearly decreasing UF rate with a UF rate starting at 1.33 times the rate that would be needed at a constant UF rate to achieve the desired post-weight; preprogrammed "profile 2" on a Fresenius 2008K machine). Ultrafiltration profiling performed using Fresenius 2008K dialysis machines in accordance with manufacturer instructions.
|
Conventional HD
n=33 Participants
Conventional HD (routine care) is the participant's standard HD prescription without UF profiling
|
|---|---|---|
|
Nadir Systolic Blood Pressure During Hemodialysis in mmHg
|
104.9 mmHg
Interval 98.4 to 111.4
|
102.1 mmHg
Interval 95.5 to 108.6
|
SECONDARY outcome
Timeframe: Every study hemodialysis treatment, up to 36 treatments per participant over 15 weeksPopulation: All participants who completed at least one phase of each study arm.
The treating nephrologist prescribed the target weight per routine clinical care. Post-dialysis weight was measured after each hemodialysis treatment in the standing position, per dialysis clinic protocol. Failed target weight achievement was defined as a difference in prescribed target weight and post-dialysis weight that was \>1 kg or \<-1 kg. Odds ratios were estimated using a mixed model (repeated measures logistic regression model).
Outcome measures
| Measure |
UF Profiling
n=33 Participants
Linear UF profiling (linearly decreasing UF rate with a UF rate starting at 1.33 times the rate that would be needed at a constant UF rate to achieve the desired post-weight; preprogrammed "profile 2" on a Fresenius 2008K machine). Ultrafiltration profiling performed using Fresenius 2008K dialysis machines in accordance with manufacturer instructions.
|
Conventional HD
n=33 Participants
Conventional HD (routine care) is the participant's standard HD prescription without UF profiling
|
|---|---|---|
|
Occurrence of Failed Target Weight Achievement (Failed Target Weight Achievement Defined as a Difference in Prescribed Target Weight and Post-dialysis Weight That is >1 kg or <-1 kg)
|
578 Number of occurrences
|
571 Number of occurrences
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15Population: All participants who completed at least one phase of each study arm.
Participants' dialysis-related symptoms (e.g. cramping) during the last week were assessed using an investigator-developed 12-question symptom questionnaire administered once weekly throughout the study (6 times per study arm). Each symptom was graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Clinically important cramping was defined as cramping ranked as moderate, severe or very severe. Odds ratios were estimated using a mixed model (repeated measures logistic regression model).
Outcome measures
| Measure |
UF Profiling
n=33 Participants
Linear UF profiling (linearly decreasing UF rate with a UF rate starting at 1.33 times the rate that would be needed at a constant UF rate to achieve the desired post-weight; preprogrammed "profile 2" on a Fresenius 2008K machine). Ultrafiltration profiling performed using Fresenius 2008K dialysis machines in accordance with manufacturer instructions.
|
Conventional HD
n=33 Participants
Conventional HD (routine care) is the participant's standard HD prescription without UF profiling
|
|---|---|---|
|
Occurrence of Patient-reported Clinically Important Cramping During Dialysis (Clinically Important Cramping Defined as Moderate, Severe, or Very Severe Cramping)
|
245 Number of occurrences
|
242 Number of occurrences
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15Population: All participants who completed at least one phase of each study arm.
Participants' dialysis-related symptoms (e.g. nausea or upset stomach) during the last week were assessed using an investigator-developed 12-question symptom questionnaire administered once weekly throughout the study (6 times per study arm). Each symptom was graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Clinically important nausea/upset stomach was defined as nausea/upset stomach ranked as moderate, severe or very severe. Odds ratios were estimated using a mixed model (repeated measures logistic regression model).
Outcome measures
| Measure |
UF Profiling
n=33 Participants
Linear UF profiling (linearly decreasing UF rate with a UF rate starting at 1.33 times the rate that would be needed at a constant UF rate to achieve the desired post-weight; preprogrammed "profile 2" on a Fresenius 2008K machine). Ultrafiltration profiling performed using Fresenius 2008K dialysis machines in accordance with manufacturer instructions.
|
Conventional HD
n=33 Participants
Conventional HD (routine care) is the participant's standard HD prescription without UF profiling
|
|---|---|---|
|
Occurrence of Patient-reported Clinically Important Nausea or Upset Stomach During Dialysis (Clinically Important Nausea or Upset Stomach Defined as Moderate, Severe, or Very Severe Nausea or Upset Stomach)
|
245 Number of occurrences
|
242 Number of occurrences
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15Population: All participants who completed at least one phase of each study arm.
Participants' dialysis-related symptoms (e.g. vomiting or throwing up) during the last week were assessed using an investigator-developed 12-question symptom questionnaire administered once weekly throughout the study (6 times per study arm). Each symptom was graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Clinically important vomiting/throwing up was defined as vomiting/throwing up ranked as moderate, severe or very severe. Odds ratios were estimated using a mixed model (repeated measures logistic regression model).
Outcome measures
| Measure |
UF Profiling
n=33 Participants
Linear UF profiling (linearly decreasing UF rate with a UF rate starting at 1.33 times the rate that would be needed at a constant UF rate to achieve the desired post-weight; preprogrammed "profile 2" on a Fresenius 2008K machine). Ultrafiltration profiling performed using Fresenius 2008K dialysis machines in accordance with manufacturer instructions.
|
Conventional HD
n=33 Participants
Conventional HD (routine care) is the participant's standard HD prescription without UF profiling
|
|---|---|---|
|
Occurrence of Patient-reported Clinically Important Vomiting or Throwing up During Dialysis (Clinically Important Vomiting or Throwing up Defined as Moderate, Severe, or Very Severe Vomiting or Throwing up)
|
245 Number of occurrences
|
242 Number of occurrences
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15Population: All participants who completed at least one phase of each study arm.
Participants' dialysis-related symptoms (e.g. dizziness or lightheadedness) during the last week were assessed using an investigator-developed 12-question symptom questionnaire administered once weekly throughout the study (6 times per study arm). Each symptom was graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Clinically important dizziness/lightheadedness was defined as dizziness/lightheadedness ranked as moderate, severe or very severe. Odds ratios were estimated using a mixed model (repeated measures logistic regression model).
Outcome measures
| Measure |
UF Profiling
n=33 Participants
Linear UF profiling (linearly decreasing UF rate with a UF rate starting at 1.33 times the rate that would be needed at a constant UF rate to achieve the desired post-weight; preprogrammed "profile 2" on a Fresenius 2008K machine). Ultrafiltration profiling performed using Fresenius 2008K dialysis machines in accordance with manufacturer instructions.
|
Conventional HD
n=33 Participants
Conventional HD (routine care) is the participant's standard HD prescription without UF profiling
|
|---|---|---|
|
Occurrence of Patient-reported Clinically Important Dizziness or Lightheadedness During Dialysis (Clinically Important Dizziness or Lightheadedness Defined as Moderate, Severe, or Very Severe Dizziness or Lightheadedness)
|
245 Number of occurrences
|
242 Number of occurrences
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15Population: All participants who completed at least one phase of each study arm.
Participants' dialysis-related symptoms (e.g. racing heart or heart palpitations) during the last week were assessed using an investigator-developed 12-question symptom questionnaire administered once weekly throughout the study (6 times per study arm). Each symptom was graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Clinically important racing heart/heart palpitations was defined as racing heart/heart palpitations ranked as moderate, severe or very severe. Odds ratios were estimated using a mixed model (repeated measures logistic regression model).
Outcome measures
| Measure |
UF Profiling
n=33 Participants
Linear UF profiling (linearly decreasing UF rate with a UF rate starting at 1.33 times the rate that would be needed at a constant UF rate to achieve the desired post-weight; preprogrammed "profile 2" on a Fresenius 2008K machine). Ultrafiltration profiling performed using Fresenius 2008K dialysis machines in accordance with manufacturer instructions.
|
Conventional HD
n=33 Participants
Conventional HD (routine care) is the participant's standard HD prescription without UF profiling
|
|---|---|---|
|
Occurrence of Patient-reported Clinically Important Racing Heart or Heart Palpitations During Dialysis (Clinically Important Racing Heart or Heart Palpitations Defined as Moderate, Severe, or Very Severe Racing Heart or Heart Palpitations)
|
245 Number of occurrences
|
242 Number of occurrences
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15Population: All participants who completed at least one phase of each study arm.
Participants' dialysis-related symptoms (e.g. chest pain) during the last week were assessed using an investigator-developed 12-question symptom questionnaire administered once weekly throughout the study (6 times per study arm). Each symptom was graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Clinically important chest pain was defined as chest pain ranked as moderate, severe or very severe. Odds ratios were estimated using a mixed model (repeated measures logistic regression model).
Outcome measures
| Measure |
UF Profiling
n=33 Participants
Linear UF profiling (linearly decreasing UF rate with a UF rate starting at 1.33 times the rate that would be needed at a constant UF rate to achieve the desired post-weight; preprogrammed "profile 2" on a Fresenius 2008K machine). Ultrafiltration profiling performed using Fresenius 2008K dialysis machines in accordance with manufacturer instructions.
|
Conventional HD
n=33 Participants
Conventional HD (routine care) is the participant's standard HD prescription without UF profiling
|
|---|---|---|
|
Occurrence of Patient-reported Clinically Important Chest Pain During Dialysis (Clinically Important Chest Pain Defined as Moderate, Severe, or Very Severe Chest Pain)
|
245 Number of occurrences
|
242 Number of occurrences
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15Population: All participants who completed at least one phase of each study arm.
Participants' dialysis-related symptoms (e.g. shortness of breath) during the last week were assessed using an investigator-developed 12-question symptom questionnaire administered once weekly throughout the study (6 times per study arm). Each symptom was graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Clinically important shortness of breath was defined as shortness of breath ranked as moderate, severe or very severe. Odds ratios were estimated using a mixed model (repeated measures logistic regression model).
Outcome measures
| Measure |
UF Profiling
n=33 Participants
Linear UF profiling (linearly decreasing UF rate with a UF rate starting at 1.33 times the rate that would be needed at a constant UF rate to achieve the desired post-weight; preprogrammed "profile 2" on a Fresenius 2008K machine). Ultrafiltration profiling performed using Fresenius 2008K dialysis machines in accordance with manufacturer instructions.
|
Conventional HD
n=33 Participants
Conventional HD (routine care) is the participant's standard HD prescription without UF profiling
|
|---|---|---|
|
Occurrence of Patient-reported Clinically Important Shortness of Breath During Dialysis (Clinically Important Shortness of Breath Defined as Moderate, Severe, or Very Severe Shortness of Breath)
|
245 Number of occurrences
|
242 Number of occurrences
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15Population: All participants who completed at least one phase of each study arm.
Participants' dialysis-related symptoms (e.g. thirst or dry mouth) during the last week were assessed using an investigator-developed 12-question symptom questionnaire administered once weekly throughout the study (6 times per study arm). Each symptom was graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Clinically important thirst/dry mouth was defined as thirst/dry mouth ranked as moderate, severe or very severe. Odds ratios were estimated using a mixed model (repeated measures logistic regression model).
Outcome measures
| Measure |
UF Profiling
n=33 Participants
Linear UF profiling (linearly decreasing UF rate with a UF rate starting at 1.33 times the rate that would be needed at a constant UF rate to achieve the desired post-weight; preprogrammed "profile 2" on a Fresenius 2008K machine). Ultrafiltration profiling performed using Fresenius 2008K dialysis machines in accordance with manufacturer instructions.
|
Conventional HD
n=33 Participants
Conventional HD (routine care) is the participant's standard HD prescription without UF profiling
|
|---|---|---|
|
Occurrence of Patient-reported Clinically Important Thirst or Dry Mouth During Dialysis (Clinically Important Thirst or Dry Mouth Defined as Moderate, Severe, or Very Severe Thirst or Dry Mouth)
|
245 Number of occurrences
|
242 Number of occurrences
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15Population: All participants who completed at least one phase of each study arm.
Participants' dialysis-related symptoms (e.g. headache) during the last week were assessed using an investigator-developed 12-question symptom questionnaire administered once weekly throughout the study (6 times per study arm). Each symptom was graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Clinically important headache was defined as headache ranked as moderate, severe or very severe. Odds ratios were estimated using a mixed model (repeated measures logistic regression model).
Outcome measures
| Measure |
UF Profiling
n=33 Participants
Linear UF profiling (linearly decreasing UF rate with a UF rate starting at 1.33 times the rate that would be needed at a constant UF rate to achieve the desired post-weight; preprogrammed "profile 2" on a Fresenius 2008K machine). Ultrafiltration profiling performed using Fresenius 2008K dialysis machines in accordance with manufacturer instructions.
|
Conventional HD
n=33 Participants
Conventional HD (routine care) is the participant's standard HD prescription without UF profiling
|
|---|---|---|
|
Occurrence of Patient-reported Clinically Important Headache During Dialysis (Clinically Important Headache Defined as Moderate, Severe, or Very Severe Headache)
|
245 Number of occurrences
|
242 Number of occurrences
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15Population: All participants who completed at least one phase of each study arm.
Participants' dialysis-related symptoms (e.g. itching) during the last week were assessed using an investigator-developed 12-question symptom questionnaire administered once weekly throughout the study (6 times per study arm). Each symptom was graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Clinically important itching was defined as itching ranked as moderate, severe or very severe. Odds ratios were estimated using a mixed model (repeated measures logistic regression model).
Outcome measures
| Measure |
UF Profiling
n=33 Participants
Linear UF profiling (linearly decreasing UF rate with a UF rate starting at 1.33 times the rate that would be needed at a constant UF rate to achieve the desired post-weight; preprogrammed "profile 2" on a Fresenius 2008K machine). Ultrafiltration profiling performed using Fresenius 2008K dialysis machines in accordance with manufacturer instructions.
|
Conventional HD
n=33 Participants
Conventional HD (routine care) is the participant's standard HD prescription without UF profiling
|
|---|---|---|
|
Occurrence of Patient-reported Clinically Important Itching During Dialysis (Clinically Important Itching Defined as Moderate, Severe, or Very Severe Itching)
|
245 Number of occurrences
|
242 Number of occurrences
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15Population: All participants who completed at least one phase of each study arm.
Participants' dialysis-related symptoms (e.g. restless legs) during the last week were assessed using an investigator-developed 12-question symptom questionnaire administered once weekly throughout the study (6 times per study arm). Each symptom was graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Clinically important restless legs was defined as restless legs ranked as moderate, severe or very severe. Odds ratios were estimated using a mixed model (repeated measures logistic regression model).
Outcome measures
| Measure |
UF Profiling
n=33 Participants
Linear UF profiling (linearly decreasing UF rate with a UF rate starting at 1.33 times the rate that would be needed at a constant UF rate to achieve the desired post-weight; preprogrammed "profile 2" on a Fresenius 2008K machine). Ultrafiltration profiling performed using Fresenius 2008K dialysis machines in accordance with manufacturer instructions.
|
Conventional HD
n=33 Participants
Conventional HD (routine care) is the participant's standard HD prescription without UF profiling
|
|---|---|---|
|
Occurrence of Patient-reported Clinically Important Restless Legs During Dialysis (Clinically Important Restless Legs Defined as Moderate, Severe, or Very Severe Restless Legs)
|
245 Number of occurrences
|
242 Number of occurrences
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15Population: All participants who completed at least one phase of each study arm.
Participants' dialysis-related symptoms (e.g. tingling or feeling of pins and needles during the last week were assessed using an investigator-developed 12-question symptom questionnaire administered once weekly throughout the study (6 times per study arm). Each symptom was graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Clinically important tingling/feeling of pins and needles was defined as tingling/feeling of pins and needles ranked as moderate, severe or very severe. Odds ratios were estimated using a mixed model (repeated measures logistic regression model).
Outcome measures
| Measure |
UF Profiling
n=33 Participants
Linear UF profiling (linearly decreasing UF rate with a UF rate starting at 1.33 times the rate that would be needed at a constant UF rate to achieve the desired post-weight; preprogrammed "profile 2" on a Fresenius 2008K machine). Ultrafiltration profiling performed using Fresenius 2008K dialysis machines in accordance with manufacturer instructions.
|
Conventional HD
n=33 Participants
Conventional HD (routine care) is the participant's standard HD prescription without UF profiling
|
|---|---|---|
|
Occurrence of Patient-reported Clinically Important Tingling or Feeling of Pins and Needles During Dialysis (Clinically Important Tingling or Feeling of Pins and Needles Defined as Moderate, Severe, or Very Severe Tingling or Feeling of Pins and Needles)
|
245 Number of occurrences
|
242 Number of occurrences
|
Adverse Events
UF Profiling
Conventional HD
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
UF Profiling
n=34 participants at risk
Linear UF profiling (linearly decreasing UF rate with a UF rate starting at 1.33 times the rate that would be needed at a constant UF rate to achieve the desired post-weight; preprogrammed "profile 2" on a Fresenius 2008K machine). Ultrafiltration profiling performed using Fresenius 2008K dialysis machines in accordance with manufacturer instructions.
|
Conventional HD
n=34 participants at risk
Conventional HD (routine care) is the participant's standard HD prescription without UF profiling
|
|---|---|---|
|
Blood and lymphatic system disorders
Epistaxis
|
2.9%
1/34 • Number of events 1 • From the time informed consent is obtained to study participation end, up to 21 weeks.
|
2.9%
1/34 • Number of events 1 • From the time informed consent is obtained to study participation end, up to 21 weeks.
|
|
Infections and infestations
Clostridium difficile diarrhea
|
2.9%
1/34 • Number of events 1 • From the time informed consent is obtained to study participation end, up to 21 weeks.
|
0.00%
0/34 • From the time informed consent is obtained to study participation end, up to 21 weeks.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/34 • From the time informed consent is obtained to study participation end, up to 21 weeks.
|
2.9%
1/34 • Number of events 1 • From the time informed consent is obtained to study participation end, up to 21 weeks.
|
|
Cardiac disorders
Hypervolemia
|
0.00%
0/34 • From the time informed consent is obtained to study participation end, up to 21 weeks.
|
2.9%
1/34 • Number of events 2 • From the time informed consent is obtained to study participation end, up to 21 weeks.
|
|
Surgical and medical procedures
Arteriovenous vascular access surgery
|
0.00%
0/34 • From the time informed consent is obtained to study participation end, up to 21 weeks.
|
2.9%
1/34 • Number of events 3 • From the time informed consent is obtained to study participation end, up to 21 weeks.
|
|
Musculoskeletal and connective tissue disorders
Bone fracture
|
0.00%
0/34 • From the time informed consent is obtained to study participation end, up to 21 weeks.
|
2.9%
1/34 • Number of events 8 • From the time informed consent is obtained to study participation end, up to 21 weeks.
|
Additional Information
Jennifer E. Flythe, MD, MPH
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place