HypotensionBP-RIDHNCT01749761
Blood Pressure Guided Biofeedback on Hemodialysis and the Reduction of IntraDialytic Hypotension
A study testing BioLogic RR and Hemodialysis without biofeedback in people with Hypotension, run by University of Calgary at 1 site in Canada.
Trial summary
It is very common for hemodialysis patients to have problems with low blood pressure while on hemodialysis. Low blood pressure on dialysis is not a good thing and it is associated with an increased risk of death and hospitalizations. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypotension
- What is being tested?
- BioLogic RR and Hemodialysis without biofeedback
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2013to Dec 2013
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic hemodialysis patients
- history of 3 of the last 12 runs with documented hypotension with symptoms or nursing interventions
Who cannot join
- <19 years
- hemodiafiltration
- expected switch in modality within next 6 months
Trial locations and contacts
1 site in 1 country.
Canada1 site
St.Paul's Hospital Hemodialysis Unit
Vancouver, British Columbia, V6Z1Y6
About this study
Official title: Blood Pressure Guided Biofeedback on Hemodialysis and the Reduction of IntraDialytic Hypotensive Episodes: A Randomized Cross Over Trial
It is very common for hemodialysis patients to have problems with low blood pressure while on hemodialysis. Low blood pressure on dialysis is not a good thing and it is associated with an increased risk of death and hospitalizations. It might be possible to minimize or even prevent these low blood pressure episodes with a software that can be added to the dialysis machine which detects the patient's changes in blood pressure and automatically slows down how much fluid is being removed from the person.
The investigators hypothesize that a blood pressure guided biofeedback system (called BioLogics RR) will result in a 30% reduction in the number of hypotensive episodes on hemodialysis.
Read the detailed description
This is a randomized cross over trial in which 30 chronic hemodialysis patients with a history of intradialytic hypotension, IDH will be randomized to receive either standard hemodialysis or hemodialysis with blood pressure guided biofeedback (BioLogics RR Comfort, B braun). After the initial period of 8 weeks patients will cross over to the other group for the final 8 weeks of the study.
The primary outcome is the reduction in the number of IDH episodes associated with patient symptoms or nursing symptoms.
- Conditions
- Hypotension
- Being tested
- BioLogic RR, Hemodialysis without biofeedback
- Keywords
- IDH, intradialytic hypotension,, hypotension on hemodialysis,, hemodialysis,, Blood pressure guided biofeedback
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioLogic RROther
Also called BioLogics Comfort RR, B Braun software
Patients will be randomized to BP guided biofeedback arm which will entail regular hemodialysis with a software program turned on to allow frequent assessment of blood pressure and automated adjustments of the ultrafiltration rate based on these blood pressure measurements. The duration of this arm is 8 weeks
Hemodialysis without biofeedbackOther
Also called Hemodialysis
patients will be randomized to Standard HD (without biofeedback technology) for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysis without biofeedback | Placebo comparator | Patients will be randomized to receive hemodialysis without biofeedback for a period of 8 weeks. Receives: Other: BioLogic RR |
| BioLogic RR biofeedback | Active comparator | Patients will receive 8 weeks of HD with BioLogic RR Blood pressure guided biofeedback. Receives: Other: Hemodialysis without biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
intradialytic hypotension episodes
A 30% reduction in the frequency of HD sessions complicated by IDH. IDH is defined as a reduction in systolic BP of > = 20 mmHg if the pre-dialysis BP is >= 100 mmHg and with patient symptoms or nursing intervention. IDH is defined as a reduction in systolic BP of >=10 mmHg if predialysis BP < = 90mm Hg and with patient symptoms or nursing interventions
Measured: By the end of the 8 week intervention period
Secondary outcomes (4)
urea clearance
Change in urea clearance
Measured: 8 weeks
Brain natriuretic peptide
change in BNP
Measured: 8 weeks
intradialytic hypotension (blood pressure criteria alone)
Reduction in the number of IDH episodes based on BP criteria alone
Measured: 8 weeks
Intradialytic symptoms
Reduction in the number of intradialytic symptoms
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionNov 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia, B. Braun Medical Inc.
- Responsible party
- Principal investigator, Dr Jennifer MacRae, University of Calgary
- Investigators
- Jennifer M MacRae, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01749761
- Sponsor's protocol ID
- H12-02619
- Acronym
- BP-RIDH
- Status last verified
- Jun 2014
- First submitted
- 12 Dec 2012
- Last updated
- 17 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Pressure Guided Biofeedback on Hemodialysis and the Reduction of IntraDialytic Hypotensive Episodes: A Randomized Cross Over Trial
- ClinicalTrials.gov ID
- NCT01749761
- Acronym / sponsor ID
- BP-RIDH / H12-02619
- Conditions
- Hypotension
- Keywords
- IDH, intradialytic hypotension,, hypotension on hemodialysis,, hemodialysis,, Blood pressure guided biofeedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- University of British Columbia, B. Braun Medical Inc.
- Study start
- Jan 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 17 Dec 2012 (estimated)
- 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.
It is very common for hemodialysis patients to have problems with low blood pressure while on hemodialysis. Low blood pressure on dialysis is not a good thing and it is associated with an increased risk of death and hospitalizations. It might be possible to minimize or even prevent these low blood pressure episodes with a software that can be added to the dialysis machine which detects the patient's changes in blood pressure and automatically slows down how much fluid is being removed from the person.
The investigators hypothesize that a blood pressure guided biofeedback system (called BioLogics RR) will result in a 30% reduction in the number of hypotensive episodes on hemodialysis.
Detailed description
This is a randomized cross over trial in which 30 chronic hemodialysis patients with a history of intradialytic hypotension, IDH will be randomized to receive either standard hemodialysis or hemodialysis with blood pressure guided biofeedback (BioLogics RR Comfort, B braun). After the initial period of 8 weeks patients will cross over to the other group for the final 8 weeks of the study.
The primary outcome is the reduction in the number of IDH episodes associated with patient symptoms or nursing symptoms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis without biofeedback | Placebo comparator | Other: BioLogic RRPatients will be randomized to receive hemodialysis without biofeedback for a period of 8 weeks. |
| BioLogic RR biofeedback | Active comparator | Other: Hemodialysis without biofeedbackPatients will receive 8 weeks of HD with BioLogic RR Blood pressure guided biofeedback. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- chronic hemodialysis patients
- history of 3 of the last 12 runs with documented hypotension with symptoms or nursing interventions
Key exclusion criteria (3 listed)
- <19 years
- hemodiafiltration
- expected switch in modality within next 6 months
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 |
|---|---|---|
| BioLogic RRAlso: BioLogics Comfort RR, B Braun softwarePatients will be randomized to BP guided biofeedback arm which will entail regular hemodialysis with a software program turned on to allow frequent assessment of blood pressure and automated adjustments of the ultrafiltration rate based on these blood pressure measurements. The duration of this arm is 8 weeks | Other | Hemodialysis without biofeedback |
| Hemodialysis without biofeedbackAlso: Hemodialysispatients will be randomized to Standard HD (without biofeedback technology) for 8 weeks | Other | BioLogic RR biofeedback |
Primary outcome
intradialytic hypotension episodes
Time frame: By the end of the 8 week intervention period
A 30% reduction in the frequency of HD sessions complicated by IDH. IDH is defined as a reduction in systolic BP of > = 20 mmHg if the pre-dialysis BP is >= 100 mmHg and with patient symptoms or nursing intervention. IDH is defined as a reduction in systolic BP of >=10 mmHg if predialysis BP < = 90mm Hg and with patient symptoms or nursing interventions
4 secondary outcomes
urea clearance
Time frame: 8 weeks
Brain natriuretic peptide
Time frame: 8 weeks
intradialytic hypotension (blood pressure criteria alone)
Time frame: 8 weeks
Intradialytic symptoms
Time frame: 8 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 17 Jun 2014.
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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.
Jennifer M MacRae, MD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioLogic RR and Hemodialysis without biofeedback in people with Hypotension, run by University of Calgary at 1 site in Canada.
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 2 inclusion and 3 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 17 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
intradialytic hypotension episodes (time frame: By the end of the 8 week intervention period). 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 17 Jun 2014.