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

Satellite Healthcare

Status: Completed

Conditions: Hemodialysis-Induced Symptom; ESRD; Fatigue

Treatments: Other: Blood Flow Rate Reduction; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT03943212

SR064RT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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102 participants in 2 patient groups

Blood Flow Rate Reduction

Experimental group

Description:

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

Treatment:

Other: Blood Flow Rate Reduction

Control

Sham Comparator group

Description:

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

Treatment:

Other: Control