ESRDNCT03943212
The Effect of Blood Flow Rate on Dialysis Recovery Time in Patients Undergoing Maintenance Hemodialysis
A study testing Blood Flow Rate Reduction in people with ESRD and Fatigue, run by Satellite Healthcare at 18 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- ESRD, Fatigue, Hemodialysis-Induced Symptom
- What is being tested?
- Blood Flow Rate Reduction
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 18 sitesUnited States
- Study dates
- 26 Sep 2017to 24 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Satellite Dialysis Capitola
Capitola, California, 95010
Satellite Dialysis Daly City
Daly City, California, 94014
Satellite Dialysis Gilroy
Gilroy, California, 95020
Satellite Dialysis Menlo Park
Menlo Park, California, 94025
Satellite Dialysis Milpitas
Milpitas, California, 95035
Satellite Dialysis Mountain View
Mountain View, California, 94040
Satellite Dialysis East San Jose
San Jose, California, 95116
Satellite Dialysis Santa Teresa
San Jose, California, 95119
Satellite Dialysis Silver Creek
San Jose, California, 95121
Satellite Dialysis South San Jose
San Jose, California, 95123
Satellite Dialysis White Road
San Jose, California, 95127
Satellite Dialysis Bascom
San Jose, California, 95128
Satellite Dialysis Stevens Creek
San Jose, California, 95129
Satellite Dialysis West San Leandro
San Leandro, California, 94577
Satellite Dialysis San Mateo
San Mateo, California, 94403
Satellite Dialysis South San Francisco
South San Francisco, California, 94080
Satellite Dialysis Sunnyvale
Sunnyvale, California, 94086
Satellite Dialysis Watsonville
Watsonville, California, 95076
About this study
Official title: The Effect of Blood Flow Rate on Dialysis Recovery Time in Patients Undergoing Maintenance Hemodialysis - A Prospective, Parallel-Group, Randomized Controlled Trial
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.
Read the 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.
- Conditions
- ESRD, Fatigue, Hemodialysis-Induced Symptom
- Being tested
- Blood Flow Rate Reduction, Control
- Keywords
- Patient-Reported Outcomes, Post-dialysis Fatigue, Dialysis Recovery Time
- Medical subject headings
- Kidney Failure, Chronic, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow Rate ReductionOther
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.
ControlOther
No changes will be made to the dialysis prescription. Patients will be surveyed regarding their dialysis recovery time and other symptoms weekly.
| Study group | Role | What they receive |
|---|---|---|
| Blood Flow Rate Reduction | Experimental | Participants will have their hemodialysis blood flow rate reduced on their regular schedule. Receives: Other: Blood Flow Rate Reduction |
| Control | Sham comparator | Participants will continue to receive regularly-scheduled hemodialysis without any changes to the prescription. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?"
Measured: 4 weeks
Secondary outcomes (1)
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start26 Sep 2017
- Primary completion24 May 2018
- Study completion24 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ESRDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel-Group, Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Satellite Healthcare
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brigitte Schiller-Moran, MD, Satellite Healthcare
- Investigators
- Brigitte Schiller, MD, Principal investigator, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03943212
- Sponsor's protocol ID
- SR064RT
- Status last verified
- May 2019
- First submitted
- 7 May 2019
- Last updated
- 9 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Blood Flow Rate on Dialysis Recovery Time in Patients Undergoing Maintenance Hemodialysis - A Prospective, Parallel-Group, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03943212
- Acronym / sponsor ID
- SR064RT
- Conditions
- ESRD, Fatigue, Hemodialysis-Induced Symptom
- Keywords
- Patient-Reported Outcomes, Post-dialysis Fatigue, Dialysis Recovery Time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Satellite HealthcareUniversity, hospital or other
- Study start
- 26 Sep 2017 (actual)
- Primary completion
- 24 May 2018 (actual)
- Study completion
- 24 May 2018 (actual)
- First posted
- 9 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel-Group, Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Blood Flow Rate Reduction | Experimental | Other: Blood Flow Rate ReductionParticipants will have their hemodialysis blood flow rate reduced on their regular schedule. |
| Control | Sham comparator | Other: ControlParticipants will continue to receive regularly-scheduled hemodialysis without any changes to the prescription. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Flow Rate ReductionHemodialysis 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. | Other | Blood Flow Rate Reduction |
| ControlNo changes will be made to the dialysis prescription. Patients will be surveyed regarding their dialysis recovery time and other symptoms weekly. | Other | Control |
Primary outcome
Dialysis Recovery Time
Time frame: 4 weeks
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?"
1 secondary outcome
London Evaluation of Illness
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brigitte Schiller, MD principal investigator
Chief Medical Officer
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Flow Rate Reduction in people with ESRD and Fatigue, run by Satellite Healthcare at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dialysis Recovery Time (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2019.