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Sponsors and Collaborators: |
University of Alabama at Birmingham Pfizer |
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Information provided by: | University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT00561431 |
In the last three decades, the mortality associated with acute renal failure (ARF) in the ICU has remained unchanged at greater than 50%, despite improvements in dialysis technology.
The primary objective is to determine whether Continuous Veno-Venous Hemodiafiltration (CVVHDF) using an ultrafiltration rate of 35 ml/hr/kg (high dose) leads to a greater reduction in all-cause ICU mortality compared to standard CVVHDF using an ultrafiltration rate of 20 ml/hr/kg.
Condition | Intervention | Phase |
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Acute Renal Failure |
Device: Standard dose of dialysis Device: high dose of dialysis |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized Prospective Study Comparing High Dose Continuous Venovenous Hemodiafiltration (CVVHDF) to Standard Dose CVVHDF in Critically Ill Patients With Acute Renal Failure at the University of Alabama at Birmingham |
Enrollment: | 212 |
Study Start Date: | July 2003 |
Estimated Study Completion Date: | November 2007 |
Arms | Assigned Interventions |
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1: Active Comparator
Standard dose CVVHDF at an effluent rate of 20 ml/kg/hr
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Device: Standard dose of dialysis
CVVHDF effluent dose of 20 ml/kg/hr
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2: Experimental
High dose CVVHDF at an effluent rate of 35 ml/kg/hr
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Device: high dose of dialysis
CVVHDF effluent rate 35 ml/kg/hr
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Although the worldwide standard for renal replacement therapy is intermittent hemodialysis(IHD), continuous renal replacement therapy (CRRT) has emerged as an alternative form of renal replacement therapy in the critical care setting due to its advaantages of slow continuous fluid remaoval, steady acid-base correction, and hemodynamic stability.
There are no standard protocols for initiating or administering CRRT, and practice patterns vary widely among institutions, with less than 25% of patients with ARF in the ICU receiving this therapy in the United States.
Various CRRT modalities are available that use diffusion, convection, or a combination of both to obtain adequate solute clearance. However, there is no consensus as to the optimal dialysis modality, adequate dialysis dose, or optimal clearance modality (convection vs. diffusion). Clinical trials are needed to determine the optimal method of adminstering CRRT, with respect to modality, dose of dialysis, and time of initiation of therapy.
Although some studies suggest that a higher dose of dialysis improves survival, there have been no prospective randomized studies comparing the effectiveness of diffusion and convection, combined together, for solute clearance.
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
ARF defined by at least one of the following:
United States, Alabama | |
The University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35233 |
Principal Investigator: | Ashita J. Tolwani, MD | The University of Alabama at Birmingham, Division of Nephrology |
Study ID Numbers: | X030108004 |
Study First Received: | November 19, 2007 |
Last Updated: | November 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00561431 |
Health Authority: | United States: Institutional Review Board |
CVVHDF Dose Study |
Renal Insufficiency Urologic Diseases Critical Illness Renal Insufficiency, Acute |
Kidney Diseases Kidney Failure, Acute Kidney Failure |