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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-26

Study Completion Date

2018-05-24

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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ESRD Fatigue Hemodialysis-Induced Symptom

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel-Group, Randomized Controlled Trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Blood Flow Rate Reduction

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

Group Type EXPERIMENTAL

Blood Flow Rate Reduction

Intervention Type OTHER

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

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

Group Type SHAM_COMPARATOR

Control

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Control

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Brigitte Schiller-Moran, MD

Chief Medical Officer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brigitte Schiller, MD

Role: PRINCIPAL_INVESTIGATOR

Chief Medical Officer

Locations

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Satellite Dialysis Capitola

Capitola, California, United States

Site Status

Satellite Dialysis Daly City

Daly City, California, United States

Site Status

Satellite Dialysis Gilroy

Gilroy, California, United States

Site Status

Satellite Dialysis Menlo Park

Menlo Park, California, United States

Site Status

Satellite Dialysis Milpitas

Milpitas, California, United States

Site Status