Hemocontrol and Blood Pressure Control in Dialysis Patients

NCT00319774 | Completed Phase 3

• 1 other identifier: HC-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

End-Stage Renal Disease; Hemodialysis

Keywords

End-stage renal disease; Hemodialysis; Hypertension; Hypotension; Blood volume; Hypervolemia; Quality of life; Biofeedback system

Outcome Measures

Primary Outcomes (1)

• 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)

Interventions

Hemocontrol Biofeedback System DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• anticipated change in renal replacement therapy
• anticipated transfer to another center
• planned renal transplantation
• enrollment in another clinical trial

Sponsors & Collaborators

• Université de Montréal: lead
• Gambro Renal Products, Inc.: collaborator

Study Sites (1)

Hopital du Sacre-Coeur de Montreal

Montreal, Quebec, H4J 1C5, Canada

Location

Related Publications (2)

• 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.

  BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic; Hypertension; Hypotension; Edema

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms

Study Officials

• Francois Madore, MD

  Faculty of Medicine, University of Montreal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 27, 2006
• First Posted: April 27, 2006
• Study Start: December 1, 2002
• Study Completion: July 1, 2003
• Last Updated: April 27, 2006

Record last verified: 2003-09

Locations

CA (1)