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NCT03943212 Clinical Trial

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

Fatigue Clinical Trial

Official title:
The Effect of Blood Flow Rate on Dialysis Recovery Time in Patients Undergoing Maintenance Hemodialysis - A Prospective, Parallel-Group, Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03943212
Other study ID # SR064RT
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 26, 2017
Est. completion date May 24, 2018

Study information
Verified date May 2019
Source Satellite Healthcare
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 102
Est. completion date May 24, 2018
Est. primary completion date May 24, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 89 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.
• Control
No changes will be made to the dialysis prescription. Patients will be surveyed regarding their dialysis recovery time and other symptoms weekly.

Locations
Country Name City State
United States 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 Bascom San Jose 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 Satellite Dialysis Stevens Creek San Jose California
United States Satellite Dialysis White Road San Jose California
United States Satellite Dialysis West San Leandro San Leandro California
United States Satellite Dialysis San Mateo San Mateo California
United States Satellite Dialysis South San Francisco South San Francisco California
United States Satellite Dialysis Sunnyvale Sunnyvale California
United States Satellite Dialysis Watsonville Watsonville California

Sponsors (1)
Lead Sponsor Collaborator
Satellite Healthcare

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Secondary 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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