Clinical trial NCT03943212: 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
Overall status: COMPLETED
Phase: NA
Conditions: ESRD
Fatigue
Hemodialysis-Induced Symptom
Keywords: Patient-Reported Outcomes
Post-dialysis Fatigue
Dialysis Recovery Time
Lead sponsor: Satellite Healthcare
Sponsor class: OTHER
First posted: 2019-05-09
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel-Group, Randomized Controlled Trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Dialysis Recovery Time
timeFrame: 4 weeks
Secondary outcomes:
measure: London Evaluation of Illness
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Capitola
country: United States
facility: Satellite Dialysis Capitola
state: California
city: Daly City
country: United States
facility: Satellite Dialysis Daly City
state: California
city: Gilroy
country: United States
facility: Satellite Dialysis Gilroy
state: California
city: Menlo Park
country: United States
facility: Satellite Dialysis Menlo Park
state: California
city: Milpitas
country: United States
facility: Satellite Dialysis Milpitas
state: California
city: Mountain View
country: United States
facility: Satellite Dialysis Mountain View
state: California
city: San Jose
country: United States
facility: Satellite Dialysis East San Jose
state: California
city: San Jose
country: United States
facility: Satellite Dialysis Santa Teresa
state: California
city: San Jose
country: United States
facility: Satellite Dialysis Silver Creek
state: California
city: San Jose
country: United States
facility: Satellite Dialysis South San Jose
state: California
city: San Jose
country: United States
facility: Satellite Dialysis White Road
state: California
city: San Jose
country: United States
facility: Satellite Dialysis Bascom
state: California
city: San Jose
country: United States
facility: Satellite Dialysis Stevens Creek
state: California
city: San Leandro
country: United States
facility: Satellite Dialysis West San Leandro
state: California
city: San Mateo
country: United States
facility: Satellite Dialysis San Mateo
state: California
city: South San Francisco
country: United States
facility: Satellite Dialysis South San Francisco
state: California
city: Sunnyvale
country: United States
facility: Satellite Dialysis Sunnyvale
state: California
city: Watsonville
country: United States
facility: Satellite Dialysis Watsonville
state: California
Study officials:
affiliation: Chief Medical Officer
name: Brigitte Schiller, MD
role: PRINCIPAL_INVESTIGATOR
References: