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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

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

Clinicaltrials.gov identifier NCT03943212

Recruitment Status Completed

First Posted May 9, 2019

Last update posted May 9, 2019

Study Description

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.

  • Condition or Disease:ESRD
    Fatigue
    Hemodialysis-Induced Symptom
  • Intervention/Treatment: Other: Blood Flow Rate Reduction
    Other: Control
  • Phase: N/A
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.

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 102 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: Parallel-Group, Randomized Controlled Trial
  • Masking: Single (Participant)
  • Primary Purpose: Treatment
  • Official Title: The Effect of Blood Flow Rate on Dialysis Recovery Time in Patients Undergoing Maintenance Hemodialysis - A Prospective, Parallel-Group, Randomized Controlled Trial
  • Actual Study Start Date: September 2017
  • Actual Primary Completion Date: May 2018
  • Actual Study Completion Date: May 2018
Arms and interventions
Arm Intervention/treatment
Experimental: Blood Flow Rate Reduction
Participants will have their hemodialysis blood flow rate reduced on their regular schedule.
Other: Blood 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.
Sham Comparator: Control
Participants will continue to receive regularly-scheduled hemodialysis without any changes to the prescription.
Other: Control
No changes will be made to the dialysis prescription. Patients will be surveyed regarding their dialysis recovery time and other symptoms weekly.
Outcome Measures
  • Primary Outcome Measures: 1. Dialysis Recovery Time [ Time Frame: 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 Outcome Measures: 1. London Evaluation of Illness [ Time Frame: 4 weeks ]
    Mean difference in change in survey responses for measures of quality of life as assessed by the London Evaluation of Illness Tool.
Eligibility Criteria
  • Ages Eligible for Study: 18 to 89 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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

Contacts and Locations
Contacts
Locations
Show 18 Study Locations
Sponsors and Collaborators

Satellite Healthcare

Investigators

Principal Investigator: Brigitte Schiller, MD Chief Medical Officer

More Information
  • Responsible Party: Satellite Healthcare
  • ClinicalTrials.gov Identifier: NCT03943212 History of Changes
  • Other Study ID Numbers: SR064RT
  • First Posted: May 9, 2019 Key Record Dates
  • Last Update Posted: May 9, 2019
  • Last Verified: May 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Satellite Healthcare: Patient-Reported Outcomes
    Post-dialysis Fatigue
    Dialysis Recovery Time
  • Additional relevant MeSH terms: Fatigue