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High Dose CVVHDF Compared to Standard Dose CVVHDF (CVVHDF)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00561431
First Posted: November 21, 2007
Last Update Posted: April 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by (Responsible Party):
Ashita Tolwani, University of Alabama at Birmingham
  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
Intervention Model: Parallel Assignment
Masking: None (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

Further study details as provided by Ashita Tolwani, 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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Ashita Tolwani, Principal Investigatorl, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00561431     History of Changes
Other Study ID Numbers: X030108004
First Submitted: November 19, 2007
First Posted: November 21, 2007
Results First Submitted: November 11, 2009
Results First Posted: March 12, 2010
Last Update Posted: April 14, 2015
Last Verified: March 2015

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

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