End-Stage Renal DiseasePhase 3NCT00319774
Hemocontrol and Blood Pressure Control in Dialysis Patients
A Phase 3 study of End-Stage Renal Disease and Hemodialysis, run by Université de Montréal at 1 site in Canada.
Trial summary
Volume overload contributes significantly to the pathogenesis of hypertension in hemodialysis patients. The Hemocontrol(HC)system (Gambro), which automatically adjusts ultrafiltration rate and dialysate conductivity according to blood volume variations during dialysis, has been suggested to improve hemodynamic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-Stage Renal Disease, Hemodialysis
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2002to Jul 2003
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- chronic hemodialysis
- on renal replacement therapy > 3 months
- at least 3 dialysis sessions and 9 hours of therapy weekly
- willing to measure blood pressure at home
- able to sign an informed consent
Who cannot join
- anticipated change in renal replacement therapy
- anticipated transfer to another center
- planned renal transplantation
- enrollment in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Hemocontrol Biofeedback System Efficiency on Long Term Blood Pressure Control, Nursing Interventions, and Quality of Life in Hemodialysis Patients: a Randomized Controlled Trial
Volume overload contributes significantly to the pathogenesis of hypertension in hemodialysis patients. The Hemocontrol(HC)system (Gambro), which automatically adjusts ultrafiltration rate and dialysate conductivity according to blood volume variations during dialysis, has been suggested to improve hemodynamic tolerance and thus facilitate fluid removal.
This randomized controlled trial was designed to compare the use of HC with standard hemodialysis to test the hypothesis that the use of the HC system may lower home blood pressure in comparison with standard hemodialysis as a primary endpoint. Secondary endpoints are a variation in the percentage of dialysis sessions requiring nurses' interventions for intra-dialytic hypotension and a change in the health-related quality of life of HD patients.
Read the detailed description
Hypertension is a common problem in patients undergoing chronic maintenance hemodialysis (HD) with a reported prevalence of 50 to 90 % [Hörl, 2002]. As a major risk factor for cardiovascular disease, hypertension contributes to the high rate of morbidity and mortality in ESRD patients [Foley, 1996; Port, 1999]. For a majority of dialysis patients, volume overload (VO) plays a major role in the pathogenesis of hypertension [Fishbane, 1996; Rahman, 2000; Ventura, 1997] and removing excess volume can often normalize blood pressure [Fishbane, 1996]. Unfortunately, correcting VO frequently proves to be difficult because of hemodynamic instability during HD sessions. As much as 20 to 50% of dialysis patients present with symptoms of intradialytic hypotension (IDH) [Santoro, 2002]. IDH increases nursing work load and negatively affects the efficacy of dialysis and the quality of life of HD patients. Different measures are used to avoid IDH, such as limitation of salt and water intake, avoidance of antihypertensive medication before dialysis, utilization of low temperature dialysate, and modeling of ultrafiltration and/or dialysate conductivity. These measures often generate mixed results.
The Hemocontrol (HC) biofeedback system (Gambro®) has been reported to reduce hemodynamic instability and hypotensive episodes during hemodialysis [Basile, 2001; Begin, 2002; Ronco, 2000; Santoro, 1994; Santoro, 1998; Santoro, 2002; Wolkotte, 2002]. The HC system consists in a fully integrated biofeedback system that monitors and regulates blood volume contraction during hemodialysis through software-driven adjustments of ultrafiltration rate and dialysate conductivity. By improving hemodynamic tolerance during dialysis, the use of the HC system has been suggested to facilitate fluid removal and correction of VO, leading to improved control of hypertension.
The present randomized controlled trial was designed to test the hypothesis that the use of the HC system would lower home BP in comparison with standard hemodialysis as a primary endpoint. Secondary endpoints are a variation in the percentage of HD sessions requiring nurses' interventions and a change in the health-related quality of life of HD patients.
- Conditions
- End-Stage Renal Disease, Hemodialysis
- Being tested
- Hemocontrol Biofeedback System
- Keywords
- End-stage renal disease, Hemodialysis, Hypertension, Hypotension, Blood volume, Hypervolemia, Quality of life, Biofeedback system
- Medical subject headings
- Kidney Failure, Chronic, Hypertension, Hypotension, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemocontrol Biofeedback SystemDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference from baseline to end of study in ambulatory blood pressure control
Secondary outcomes (2)
Episodes of intra-dialytic hypotension requiring nursing interventions
Health-related quality of life (using the Kidney Disease and Quality of Life Short Form)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2006 (estimated)
- Study startDec 2002
- Study completionJul 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for End-Stage Renal DiseaseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- Gambro Renal Products, Inc.
- Investigators
- Francois Madore, MD, Principal investigator, Faculty of Medicine, University of Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00319774
- Sponsor's protocol ID
- HC-01
- Status last verified
- Sep 2003
- First submitted
- 27 Apr 2006
- Last updated
- 27 Apr 2006
- Results posted
- No
Publications
C. Déziel, M. Zellweger, R. Comeau, A. Valleau, S. Raymond-Carrier, F. Madore. Home Blood Pressure Management with Automated Blood Volume Regulation in Hemodialysis Patients: A Prospective Randomized Controlled Trial. J. Am. Soc. Nephrol. 15:594A, October 2004.
C. Déziel, M. Zellweger, R. Comeau, M. Kerangueven, S. Raymond-Carrier, F. Madore. Hemodynamic Stability during Hemodialysis and Quality of Life with Automated Blood Volume Regulation: A Prospective Randomized Controlled Trial. J. Am. Soc. Nephrol. 15:47A, October 2004
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Hemocontrol Biofeedback System Efficiency on Long Term Blood Pressure Control, Nursing Interventions, and Quality of Life in Hemodialysis Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00319774
- Acronym / sponsor ID
- HC-01
- Conditions
- End-Stage Renal Disease, Hemodialysis
- Keywords
- End-stage renal disease, Hemodialysis, Hypertension, Hypotension, Blood volume, Hypervolemia, Quality of life, Biofeedback system
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Collaborators
- Gambro Renal Products, Inc.
- Study start
- Dec 2002
- Study completion
- Jul 2003
- First posted
- 27 Apr 2006 (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.
Volume overload contributes significantly to the pathogenesis of hypertension in hemodialysis patients. The Hemocontrol(HC)system (Gambro), which automatically adjusts ultrafiltration rate and dialysate conductivity according to blood volume variations during dialysis, has been suggested to improve hemodynamic tolerance and thus facilitate fluid removal.
This randomized controlled trial was designed to compare the use of HC with standard hemodialysis to test the hypothesis that the use of the HC system may lower home blood pressure in comparison with standard hemodialysis as a primary endpoint. Secondary endpoints are a variation in the percentage of dialysis sessions requiring nurses' interventions for intra-dialytic hypotension and a change in the health-related quality of life of HD patients.
Detailed description
Hypertension is a common problem in patients undergoing chronic maintenance hemodialysis (HD) with a reported prevalence of 50 to 90 % [Hörl, 2002]. As a major risk factor for cardiovascular disease, hypertension contributes to the high rate of morbidity and mortality in ESRD patients [Foley, 1996; Port, 1999]. For a majority of dialysis patients, volume overload (VO) plays a major role in the pathogenesis of hypertension [Fishbane, 1996; Rahman, 2000; Ventura, 1997] and removing excess volume can often normalize blood pressure [Fishbane, 1996]. Unfortunately, correcting VO frequently proves to be difficult because of hemodynamic instability during HD sessions. As much as 20 to 50% of dialysis patients present with symptoms of intradialytic hypotension (IDH) [Santoro, 2002]. IDH increases nursing work load and negatively affects the efficacy of dialysis and the quality of life of HD patients. Different measures are used to avoid IDH, such as limitation of salt and water intake, avoidance of antihypertensive medication before dialysis, utilization of low temperature dialysate, and modeling of ultrafiltration and/or dialysate conductivity. These measures often generate mixed results.
The Hemocontrol (HC) biofeedback system (Gambro®) has been reported to reduce hemodynamic instability and hypotensive episodes during hemodialysis [Basile, 2001; Begin, 2002; Ronco, 2000; Santoro, 1994; Santoro, 1998; Santoro, 2002; Wolkotte, 2002]. The HC system consists in a fully integrated biofeedback system that monitors and regulates blood volume contraction during hemodialysis through software-driven adjustments of ultrafiltration rate and dialysate conductivity. By improving hemodynamic tolerance during dialysis, the use of the HC system has been suggested to facilitate fluid removal and correction of VO, leading to improved control of hypertension.
The present randomized controlled trial was designed to test the hypothesis that the use of the HC system would lower home BP in comparison with standard hemodialysis as a primary endpoint. Secondary endpoints are a variation in the percentage of HD sessions requiring nurses' interventions and a change in the health-related quality of life of HD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years or older
- chronic hemodialysis
- on renal replacement therapy > 3 months
- at least 3 dialysis sessions and 9 hours of therapy weekly
- willing to measure blood pressure at home
Key exclusion criteria (4 listed)
- anticipated change in renal replacement therapy
- anticipated transfer to another center
- planned renal transplantation
- enrollment in another clinical trial
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 |
|---|---|---|
| Hemocontrol Biofeedback System | Device | – |
Primary outcome
Difference from baseline to end of study in ambulatory blood pressure control
2 secondary outcomes
Episodes of intra-dialytic hypotension requiring nursing interventions
Health-related quality of life (using the Kidney Disease and Quality of Life Short Form)
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 27 Apr 2006.
- BackgroundC. Déziel, M. Zellweger, R. Comeau, A. Valleau, S. Raymond-Carrier, F. Madore. Home Blood Pressure Management with Automated Blood Volume Regulation in Hemodialysis Patients: A Prospective Randomized Controlled Trial. J. Am. Soc. Nephrol. 15:594A, October 2004.
- BackgroundC. Déziel, M. Zellweger, R. Comeau, M. Kerangueven, S. Raymond-Carrier, F. Madore. Hemodynamic Stability during Hemodialysis and Quality of Life with Automated Blood Volume Regulation: A Prospective Randomized Controlled Trial. J. Am. Soc. Nephrol. 15:47A, October 2004
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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.
Francois Madore, MD principal investigator
Faculty of Medicine, University of Montreal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of End-Stage Renal Disease and Hemodialysis, run by Université de Montréal 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 6 inclusion and 4 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 27 Apr 2006. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Difference from baseline to end of study in ambulatory blood pressure control. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00319774, which also lists 2 linked publications.
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 27 Apr 2006.