Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

High Dose CVVHDF Compared to Standard Dose CVVHDF

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00561431
First received: November 19, 2007
Last updated: February 24, 2010
Last verified: February 2010
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of Participants Alive at 30 Days After Enrollment Compared Between High Dose Versus Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF) [ Time Frame: Up to 30 days ] [ Designated as safety issue: No ]
    The primary objective is to determine whether Continuous Venovenous Hemodiafiltration (CVVHDF) using an effluent rate of 35 ml/hr/kg (high dose) leads to an increased participant survival time as compared to CVVHDF using the standard effluent rate of 25 ml/hr/kg as measured by days on continuous renal replacement therapy (CRRT) at enrollment up to 30 days.


Secondary Outcome Measures:
  • Recovery of Renal Function, Defined as Not Requiring Dialysis After Discontinuation of CRRT [ Time Frame: Up to 30 days ] [ Designated as safety issue: No ]
    The number of participants who recover renal function at 30 days after enrollment in each arm.


Enrollment: 200
Study Start Date: July 2003
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Standard dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 20 ml/kg/hr
Device: Standard dose of dialysis
Continuous Venovenous Hemodiafiltration (CVVHDF) effluent dose of 20 ml/kg/hr
Experimental: 2
High dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 35 ml/kg/hr
Device: High dose of dialysis
Continuous Venovenous Hemodiafiltration (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 advantages of slow continuous fluid removal, 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 administering 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.

Exclusion Criteria

  • Patients with end stage renal disease
  • Patients who have had more than one previous dialysis session for acute or chronic renal failure during the current hospitalization
  • Patient weight greater than 125 kg
  • Patient weight less than 50 kg
  • Pregnancy
  • Prisoner
  • Non-candidacy for continuous renal replacement therapy (CRRT)
  • Patient/surrogate refusal
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Ashita Tolwani M.D., University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00561431     History of Changes
Other Study ID Numbers: X030108004
Study First Received: November 19, 2007
Results First Received: November 11, 2009
Last Updated: February 24, 2010
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on November 25, 2014