Hemocontrol and Blood Pressure Control in Dialysis Patients

This study has been completed.
Sponsor:
Collaborator:
Gambro Renal Products, Inc.
Information provided by:
Université de Montréal
ClinicalTrials.gov Identifier:
NCT00319774
First received: April 27, 2006
Last updated: NA
Last verified: September 2003
History: No changes posted
  Purpose

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
End-Stage Renal Disease
Hemodialysis
Device: Hemocontrol Biofeedback System
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Université de Montréal:

Primary Outcome Measures:
  • Difference from baseline to end of study in ambulatory blood pressure control

Secondary Outcome Measures:
  • Episodes of intra-dialytic hypotension requiring nursing interventions
  • Health-related quality of life (using the Kidney Disease and Quality of Life Short Form)

Estimated Enrollment: 60
Study Start Date: December 2002
Estimated Study Completion Date: July 2003
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • anticipated change in renal replacement therapy
  • anticipated transfer to another center
  • planned renal transplantation
  • enrollment in another clinical trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00319774

Locations
Canada, Quebec
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada, H4J 1C5
Sponsors and Collaborators
Université de Montréal
Gambro Renal Products, Inc.
Investigators
Principal Investigator: Francois Madore, MD Faculty of Medicine, University of Montreal
  More Information

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

ClinicalTrials.gov Identifier: NCT00319774     History of Changes
Other Study ID Numbers: HC-01
Study First Received: April 27, 2006
Last Updated: April 27, 2006
Health Authority: Canada: Health Canada

Keywords provided by Université de Montréal:
End-stage renal disease
Hemodialysis
Hypertension
Hypotension
Blood volume
Hypervolemia
Quality of life
Biofeedback system

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on September 30, 2014