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

Primary Purpose

ESRD, Fatigue, Hemodialysis-Induced Symptom

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood Flow Rate Reduction
Control
Sponsored by
Satellite Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ESRD focused on measuring Patient-Reported Outcomes, Post-dialysis Fatigue, Dialysis Recovery Time

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Satellite Dialysis Capitola
  • Satellite Dialysis Daly City
  • Satellite Dialysis Gilroy
  • Satellite Dialysis Menlo Park
  • Satellite Dialysis Milpitas
  • Satellite Dialysis Mountain View
  • Satellite Dialysis East San Jose
  • Satellite Dialysis Santa Teresa
  • Satellite Dialysis Silver Creek
  • Satellite Dialysis South San Jose
  • Satellite Dialysis White Road
  • Satellite Dialysis Bascom
  • Satellite Dialysis Stevens Creek
  • Satellite Dialysis West San Leandro
  • Satellite Dialysis San Mateo
  • Satellite Dialysis South San Francisco
  • Satellite Dialysis Sunnyvale
  • Satellite Dialysis Watsonville

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Blood Flow Rate Reduction

Control

Arm Description

Participants will have their hemodialysis blood flow rate reduced on their regular schedule.

Participants will continue to receive regularly-scheduled hemodialysis without any changes to the prescription.

Outcomes

Primary Outcome Measures

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?"

Secondary Outcome Measures

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.

Full Information

First Posted
May 7, 2019
Last Updated
May 7, 2019
Sponsor
Satellite Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT03943212
Brief Title
The Effect of Blood Flow Rate on Dialysis Recovery Time in Patients Undergoing Maintenance Hemodialysis
Official Title
The Effect of Blood Flow Rate on Dialysis Recovery Time in Patients Undergoing Maintenance Hemodialysis - A Prospective, Parallel-Group, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
September 26, 2017 (Actual)
Primary Completion Date
May 24, 2018 (Actual)
Study Completion Date
May 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Satellite Healthcare

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ESRD, Fatigue, Hemodialysis-Induced Symptom
Keywords
Patient-Reported Outcomes, Post-dialysis Fatigue, Dialysis Recovery Time

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel-Group, Randomized Controlled Trial
Masking
Participant
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blood Flow Rate Reduction
Arm Type
Experimental
Arm Description
Participants will have their hemodialysis blood flow rate reduced on their regular schedule.
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Participants will continue to receive regularly-scheduled hemodialysis without any changes to the prescription.
Intervention Type
Other
Intervention Name(s)
Blood Flow Rate Reduction
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
No changes will be made to the dialysis prescription. Patients will be surveyed regarding their dialysis recovery time and other symptoms weekly.
Primary Outcome Measure Information:
Title
Dialysis Recovery Time
Description
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?"
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
London Evaluation of Illness
Description
Mean difference in change in survey responses for measures of quality of life as assessed by the London Evaluation of Illness Tool.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brigitte Schiller, MD
Organizational Affiliation
Chief Medical Officer
Official's Role
Principal Investigator
Facility Information:
Facility Name
Satellite Dialysis Capitola
City
Capitola
State/Province
California
ZIP/Postal Code
95010
Country
United States
Facility Name
Satellite Dialysis Daly City
City
Daly City
State/Province
California
ZIP/Postal Code
94014
Country
United States
Facility Name
Satellite Dialysis Gilroy
City
Gilroy
State/Province
California
ZIP/Postal Code
95020
Country
United States
Facility Name
Satellite Dialysis Menlo Park
City
Menlo Park
State/Province
California
ZIP/Postal Code
94025
Country
United States
Facility Name
Satellite Dialysis Milpitas
City
Milpitas
State/Province
California
ZIP/Postal Code
95035
Country
United States
Facility Name
Satellite Dialysis Mountain View
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Satellite Dialysis East San Jose
City
San Jose
State/Province
California
ZIP/Postal Code
95116
Country
United States
Facility Name
Satellite Dialysis Santa Teresa
City
San Jose
State/Province
California
ZIP/Postal Code
95119
Country
United States
Facility Name
Satellite Dialysis Silver Creek
City
San Jose
State/Province
California
ZIP/Postal Code
95121
Country
United States
Facility Name
Satellite Dialysis South San Jose
City
San Jose
State/Province
California
ZIP/Postal Code
95123
Country
United States
Facility Name
Satellite Dialysis White Road
City
San Jose
State/Province
California
ZIP/Postal Code
95127
Country
United States
Facility Name
Satellite Dialysis Bascom
City
San Jose
State/Province
California
ZIP/Postal Code
95128
Country
United States
Facility Name
Satellite Dialysis Stevens Creek
City
San Jose
State/Province
California
ZIP/Postal Code
95129
Country
United States
Facility Name
Satellite Dialysis West San Leandro
City
San Leandro
State/Province
California
ZIP/Postal Code
94577
Country
United States
Facility Name
Satellite Dialysis San Mateo
City
San Mateo
State/Province
California
ZIP/Postal Code
94403
Country
United States
Facility Name
Satellite Dialysis South San Francisco
City
South San Francisco
State/Province
California
ZIP/Postal Code
94080
Country
United States
Facility Name
Satellite Dialysis Sunnyvale
City
Sunnyvale
State/Province
California
ZIP/Postal Code
94086
Country
United States
Facility Name
Satellite Dialysis Watsonville
City
Watsonville
State/Province
California
ZIP/Postal Code
95076
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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