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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• ESRD
• Fatigue
• Hemodialysis-Induced Symptom

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