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High Dose CVVHDF Compared to Standard Dose CVVHDF
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: University of Alabama at Birmingham
Pfizer
Information provided by: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00561431
  Purpose

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
Acute Renal Failure
Device: Standard dose of dialysis
Device: high dose of dialysis
Phase III

MedlinePlus related topics: Kidney Failure
U.S. FDA Resources
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

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • The primary objective is to determine whether CVVHDF using an ultrafiltration rate of 35 ml/hr/kg (high dose) leads to a greater reduction in all-cause mortality compared to standard CVVHDF using an ultrafiltration rate of 20 ml/hr/kg. [ Time Frame: The prescribed ultafiltration dose will be delivered for the duration of CRRT or until either ICU discharge or 30 days whichever occurs first ]

Enrollment: 212
Study Start Date: July 2003
Estimated Study Completion Date: November 2007
Arms Assigned Interventions
1: Active Comparator
Standard dose CVVHDF at an effluent rate of 20 ml/kg/hr
Device: Standard dose of dialysis
CVVHDF effluent dose of 20 ml/kg/hr
2: Experimental
High dose CVVHDF at an effluent rate of 35 ml/kg/hr
Device: high dose of dialysis
CVVHDF effluent rate 35 ml/kg/hr

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female > or equal to 19 yrs of age
  • ARF defined by at least one of the following:

    • Volume overload from inadequate urine output despite diuretic agents.
    • Oliguria (urine output < 200 ml/12hrs) despite fluid resuscitation and diuretic administration.
    • Anuria (urine output < 50 ml/12 hrs).
    • Acute azotemia (BUN > or equal to 80 mg/dl).
    • Acute hyperkalemia not responsive to medication (K+ > or equal to 6.5mmol/L)
    • An increase in serum creatinine of > 2.5 mg/dl from normal values or a sustained rise in serum creatinine of > or equal to 1 mg/dl over baseline.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00561431

Locations
United States, Alabama
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham
Pfizer
Investigators
Principal Investigator: Ashita J. Tolwani, MD The University of Alabama at Birmingham, Division of Nephrology
  More Information

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

Keywords provided by University of Alabama at Birmingham:
CVVHDF Dose Study

Study placed in the following topic categories:
Renal Insufficiency
Urologic Diseases
Critical Illness
Renal Insufficiency, Acute
Kidney Diseases
Kidney Failure, Acute
Kidney Failure

ClinicalTrials.gov processed this record on January 15, 2009