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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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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:Fatigue
    Hemodialysis-Induced Symptom
    ESRD
  • 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

United States, California
Satellite Dialysis Capitola
Capitola

United States, California
Satellite Dialysis Daly City
Daly City

United States, California
Satellite Dialysis Gilroy
Gilroy

United States, California
Satellite Dialysis Menlo Park
Menlo Park

United States, California
Satellite Dialysis Milpitas
Milpitas

United States, California
Satellite Dialysis Mountain View
Mountain View

United States, California
Satellite Dialysis East San Jose
San Jose

United States, California
Satellite Dialysis Santa Teresa
San Jose

United States, California
Satellite Dialysis Silver Creek
San Jose

United States, California
Satellite Dialysis South San Jose
San Jose

United States, California
Satellite Dialysis White Road
San Jose

United States, California
Satellite Dialysis Bascom
San Jose

United States, California
Satellite Dialysis Stevens Creek
San Jose

United States, California
Satellite Dialysis West San Leandro
San Leandro

United States, California
Satellite Dialysis San Mateo
San Mateo

United States, California
Satellite Dialysis South San Francisco
South San Francisco

United States, California
Satellite Dialysis Sunnyvale
Sunnyvale

United States, California
Satellite Dialysis Watsonville
Watsonville

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