ESRD, Fatigue, Hemodialysis-Induced Symptom
Conditions
Keywords
Patient-Reported Outcomes, Post-dialysis Fatigue, Dialysis Recovery Time
Brief summary
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
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.
Interventions
OTHERBlood Flow Rate Reduction
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.
OTHERControl
No changes will be made to the dialysis prescription. Patients will be surveyed regarding their dialysis recovery time and other symptoms weekly.
Sponsors
Satellite Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Parallel-Group, Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dialysis Recovery Time | 4 weeks | 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? |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| London Evaluation of Illness | 4 weeks | Mean difference in change in survey responses for measures of quality of life as assessed by the London Evaluation of Illness Tool. |
Countries
United States
Outcome results
None listed