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Sponsors and Collaborators: |
University of Montreal Gambro Renal Products, Inc. |
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Information provided by: | University of Montreal |
ClinicalTrials.gov Identifier: | NCT00319774 |
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.
Condition | Intervention | Phase |
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End-Stage Renal Disease Hemodialysis |
Device: Hemocontrol Biofeedback System |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy 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 |
Estimated Enrollment: | 60 |
Study Start Date: | December 2002 |
Estimated Study Completion Date: | July 2003 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Quebec | |
Hopital du Sacre-Coeur de Montreal | |
Montreal, Quebec, Canada, H4J 1C5 |
Principal Investigator: | Francois Madore, MD | Faculty of Medicine, University of Montreal |
Study ID Numbers: | HC-01 |
Study First Received: | April 27, 2006 |
Last Updated: | April 27, 2006 |
ClinicalTrials.gov Identifier: | NCT00319774 |
Health Authority: | Canada: Health Canada |
End-stage renal disease Hemodialysis Hypertension Hypotension |
Blood volume Hypervolemia Quality of life Biofeedback system |
Hypotension Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic |
Quality of Life Kidney Diseases Kidney Failure Hypertension |