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Hemocontrol and Blood Pressure Control in Dialysis Patients

NCT00319774 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2006-04-27

No results posted yet for this study

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

Interventions

DEVICE

Hemocontrol Biofeedback System

Sponsors & Collaborators

  • Gambro Renal Products, Inc.

    collaborator INDUSTRY

  • Université de Montréal

    lead OTHER

Principal Investigators

  • Francois Madore, MD · Faculty of Medicine, University of Montreal

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-12-31
Completion
2003-07-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00319774 on ClinicalTrials.gov