Hemodialysis Clinical Trial
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
Verified date | September 2003 |
Source | Université de Montréal |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | July 2003 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Hopital du Sacre-Coeur de Montreal | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Université de Montréal | Gambro Renal Products, Inc. |
Canada,
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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference from baseline to end of study in ambulatory blood pressure control | |||
Secondary | Episodes of intra-dialytic hypotension requiring nursing interventions | |||
Secondary | Health-related quality of life (using the Kidney Disease and Quality of Life Short Form) |
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