The Effect of Blood Flow Rate on Dialysis Recovery Time in Patients Undergoing Maintenance Hemodialysis

Study Overview
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Brief Summary
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A majority of patients with end-stage renal disease (ESRD) on in-center hemodialysis (HD) require several hours to recover from fatigue after an HD session. Evidence for practical interventions to improve this recovery time from conventional in-center HD is lacking. This study investigates the effects of reducing HD blood flow rates on patients' self-reported post-dialysis fatigue.

Detailed Description
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Post-dialysis fatigue reduces patients' quality of life and is also associated with cardiovascular events and mortality. Dialysis recovery time (DRT) is a measure of post-dialysis fatigue. Internationally, it has been found that more than a quarter of maintenance HD patients report >6 hours of DRT. The interventions showing the most improvement in DRT involve increases in treatment time, suggesting that post-dialysis fatigue may be in part related to the rate of solute clearance. Solute clearance rate is just one part of extending dialysis time, and its effect on DRT in patients undergoing typical-length dialysis sessions is not known. There is scant evidence to guide blood flow rate prescriptions aside from meeting clearance targets. Blood flow rate reductions are easily-implementable interventions that would slow solute clearance rates and may have an effect on post-dialysis fatigue.

Official Title
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The Effect of Blood Flow Rate on Dialysis Recovery Time in Patients Undergoing Maintenance Hemodialysis - A Prospective, Parallel-Group, Randomized Controlled Trial

Conditions
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ESRD, Fatigue, Hemodialysis-Induced Symptom

Intervention / Treatment
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* Other: Blood Flow Rate Reduction
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A diagnosis of end-stage renal disease undergoing hemodialysis in the San Francisco Bay Area at approved Satellite Healthcare dialysis centers. Dialysis recovery time of 6 or more hours. Not hospitalized in the 7 days prior to study Exclusion Criteria: Currently or possibly pregnant, currently trying to become pregnant Inability to provide informed consent Inability to provide responses to survey questions Planned move away from the current hemodialysis center within the study period Undergoing nocturnal hemodialysis, planned changed to nocturnal or peritoneal dialysis, planned kidney transplant within the study period, or other major planned change in hemodialysis prescription Primary nephrologist objection to enrollment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel-Group, Randomized Controlled Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blood Flow Rate Reduction<br>Participants will have their hemodialysis blood flow rate reduced on their regular schedule. | Other: Blood Flow Rate Reduction<br>* Hemodialysis blood flow rate will be reduced by 100 mL/min, or to a minimum of 300 mL/min, whichever is higher. Patients will be surveyed regarding their dialysis recovery time and other symptoms weekly.<br>|
| Sham Comparator: Control<br>Participants will continue to receive regularly-scheduled hemodialysis without any changes to the prescription. | Other: Control<br>* No changes will be made to the dialysis prescription. Patients will be surveyed regarding their dialysis recovery time and other symptoms weekly.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dialysis Recovery Time | Mean difference in change in Dialysis Recovery Time between the Blood Flow Rate Reduction group and the Control group. Dialysis recovery time is measured by asking the question, How long did it take you to recover from dialysis? | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| London Evaluation of Illness | Mean difference in change in survey responses for measures of quality of life as assessed by the London Evaluation of Illness Tool. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient-Reported Outcomes, Post-dialysis Fatigue, Dialysis Recovery Time