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

Not Applicable
Completed
Conditions
ESRD
Hemodialysis-Induced Symptom
Fatigue
Registration Number
NCT03943212
Lead Sponsor
Satellite Healthcare
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
102
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Dialysis Recovery Time4 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 Outcome Measures
NameTimeMethod
London Evaluation of Illness4 weeks

Mean difference in change in survey responses for measures of quality of life as assessed by the London Evaluation of Illness Tool.

Trial Locations

Locations (18)

Satellite Dialysis Capitola

🇺🇸

Capitola, California, United States

Satellite Dialysis Daly City

🇺🇸

Daly City, California, United States

Satellite Dialysis Gilroy

🇺🇸

Gilroy, California, United States

Satellite Dialysis Menlo Park

🇺🇸

Menlo Park, California, United States

Satellite Dialysis Milpitas

🇺🇸

Milpitas, California, United States

Satellite Dialysis Mountain View

🇺🇸

Mountain View, California, United States

Satellite Dialysis East San Jose

🇺🇸

San Jose, California, United States

Satellite Dialysis Santa Teresa

🇺🇸

San Jose, California, United States

Satellite Dialysis Silver Creek

🇺🇸

San Jose, California, United States

Satellite Dialysis South San Jose

🇺🇸

San Jose, California, United States

Scroll for more (8 remaining)
Satellite Dialysis Capitola
🇺🇸Capitola, California, United States

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