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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood Flow Rate Reduction | Experimental | Participants will have their hemodialysis blood flow rate reduced on their regular schedule. |
|
| Control | Sham Comparator | Participants will continue to receive regularly-scheduled hemodialysis without any changes to the prescription. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Flow Rate Reduction | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brigitte Schiller, MD | Chief Medical Officer | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Satellite Dialysis Capitola | Capitola | California | 95010 | United States | ||
| Satellite Dialysis Daly City |
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Parallel-Group, Randomized Controlled Trial
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| Control | Other | No changes will be made to the dialysis prescription. Patients will be surveyed regarding their dialysis recovery time and other symptoms weekly. |
|
| Daly City |
| California |
| 94014 |
| United States |
| Satellite Dialysis Gilroy | Gilroy | California | 95020 | United States |
| Satellite Dialysis Menlo Park | Menlo Park | California | 94025 | United States |
| Satellite Dialysis Milpitas | Milpitas | California | 95035 | United States |
| Satellite Dialysis Mountain View | Mountain View | California | 94040 | United States |
| Satellite Dialysis East San Jose | San Jose | California | 95116 | United States |
| Satellite Dialysis Santa Teresa | San Jose | California | 95119 | United States |
| Satellite Dialysis Silver Creek | San Jose | California | 95121 | United States |
| Satellite Dialysis South San Jose | San Jose | California | 95123 | United States |
| Satellite Dialysis White Road | San Jose | California | 95127 | United States |
| Satellite Dialysis Bascom | San Jose | California | 95128 | United States |
| Satellite Dialysis Stevens Creek | San Jose | California | 95129 | United States |
| Satellite Dialysis West San Leandro | San Leandro | California | 94577 | United States |
| Satellite Dialysis San Mateo | San Mateo | California | 94403 | United States |
| Satellite Dialysis South San Francisco | South San Francisco | California | 94080 | United States |
| Satellite Dialysis Sunnyvale | Sunnyvale | California | 94086 | United States |
| Satellite Dialysis Watsonville | Watsonville | California | 95076 | United States |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
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