The Effect of Blood Flow Rate on Dialysis Recovery Time in Patients Undergoing Maintenance Hemodialysis
1 other identifier
interventional
102
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2017
Shorter than P25 for not_applicable
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 24, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 24, 2018
CompletedFirst Submitted
Initial submission to the registry
May 7, 2019
CompletedFirst Posted
Study publicly available on registry
May 9, 2019
CompletedMay 9, 2019
May 1, 2019
8 months
May 7, 2019
May 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
London Evaluation of Illness
4 weeks
Study Arms (2)
Blood Flow Rate Reduction
EXPERIMENTALParticipants will have their hemodialysis blood flow rate reduced on their regular schedule.
Control
SHAM COMPARATORParticipants will continue to receive regularly-scheduled hemodialysis without any changes to the prescription.
Interventions
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.
No changes will be made to the dialysis prescription. Patients will be surveyed regarding their dialysis recovery time and other symptoms weekly.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Satellite Dialysis Capitola
Capitola, California, 95010, United States
Satellite Dialysis Daly City
Daly City, California, 94014, United States
Satellite Dialysis Gilroy
Gilroy, California, 95020, United States
Satellite Dialysis Menlo Park
Menlo Park, California, 94025, United States
Satellite Dialysis Milpitas
Milpitas, California, 95035, United States
Satellite Dialysis Mountain View
Mountain View, California, 94040, United States
Satellite Dialysis East San Jose
San Jose, California, 95116, United States
Satellite Dialysis Santa Teresa
San Jose, California, 95119, United States
Satellite Dialysis Silver Creek
San Jose, California, 95121, United States
Satellite Dialysis South San Jose
San Jose, California, 95123, United States
Satellite Dialysis White Road
San Jose, California, 95127, United States
Satellite Dialysis Bascom
San Jose, California, 95128, United States
Satellite Dialysis Stevens Creek
San Jose, California, 95129, United States
Satellite Dialysis West San Leandro
San Leandro, California, 94577, United States
Satellite Dialysis San Mateo
San Mateo, California, 94403, United States
Satellite Dialysis South San Francisco
South San Francisco, California, 94080, United States
Satellite Dialysis Sunnyvale
Sunnyvale, California, 94086, United States
Satellite Dialysis Watsonville
Watsonville, California, 95076, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brigitte Schiller, MD
Chief Medical Officer
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Medical Officer
Study Record Dates
First Submitted
May 7, 2019
First Posted
May 9, 2019
Study Start
September 26, 2017
Primary Completion
May 24, 2018
Study Completion
May 24, 2018
Last Updated
May 9, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share