Acute Renal Failure Trial Network (ATN) Study

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00076219
First received: January 15, 2004
Last updated: August 16, 2013
Last verified: August 2013
  Purpose

This is a multi-center, prospective, randomized, parallel-group trial of an intensive strategy vs conventional strategy of renal replacement therapy for the treatment of acute renal failure secondary to acute tubular necrosis in critically ill patients. The primary hypothesis is that the intensive strategy will reduce 60-day all cause mortality by 10% compared to the conventional strategy - i.e.,a reduction from 55% in the conventional arm to 45% in the intensive arm. Secondary outcomes are 60-day in-hospital all-cause mortality, 1-year all cause mortality, and recovery of renal function by day 28. The study will recruit 1164 patients over a period of 3 years, 8 months and each patient will be actively followed for 60 days.


Condition Intervention Phase
Acute Renal Failure
Procedure: renal replacement therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CSP #530 - Intensive vs. Conventional Renal Support in Acute Renal Failure

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 60-day All-cause Mortality [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
    60-day all-cause mortality


Enrollment: 1124
Study Start Date: October 2003
Study Completion Date: July 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intensive renal replacement therapy
In the intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 6 times per week, and continuous venovenous hemodiafiltration was provided at 35 mL/kg/hour.
Procedure: renal replacement therapy
renal replacement therapy
Active Comparator: Less-intensive renal replacement therapy
In the less-intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 3 times per week, and continuous venovenous hemodiafiltration was provided at 20 mL/kg/hour.
Procedure: renal replacement therapy
renal replacement therapy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute renal failure clinically consistent with a diagnosis of acute tubular necrosis
  • Plan for renal replacement therapy by clinical team
  • Receiving care in a critical care unit
  • One non-renal organ failure or sepsis
  • Age 18 or older
  • Patient or surrogate provides informed consent

Exclusion Criteria:

  • Baseline serum creatinine > 2 mg/dL (177 mol/L) in males, > 1.5 mg/dL (133 mol/L) in females
  • Acute renal failure clinically believed to be due to an etiology other than acute tubular necrosis
  • More than 72 hours since meeting both of the following conditions:

    1. Fulfillment of the definition of ARF; and
    2. BUN > 100 mg/dL (36 mmol/L)
  • More than 1 hemodialysis treatment or more than 24 hours since starting continuous renal replacement therapy
  • Prior kidney transplant
  • Pregnancy
  • Prisoner
  • Weight > 128.5 kg
  • Non-candidacy for renal replacement therapy
  • Moribund state
  • Patient not expected to survive 28 days because of underlying terminal chronic medical condition
  • Comfort-measures-only status
  • Participation in a concurrent interventional study
  • Patient/surrogate refusal
  • Physician 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: NCT00076219

  Hide Study Locations
Locations
United States, Arkansas
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
No. Little Rock, Arkansas, United States, 72114-1706
United States, California
VA Medical Center, San Francisco
San Francisco, California, United States, 94121
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, United States, 90073
United States, Colorado
VA Eastern Colorado Health Care System, Denver
Denver, Colorado, United States, 80220
United States, Connecticut
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, United States, 06516
United States, Florida
VA Medical Center, Miami
Miami, Florida, United States, 33125
United States, Georgia
VA Medical Center, Augusta
Augusta, Georgia, United States, 30904
United States, Indiana
Richard Roudebush VA Medical Center, Indianapolis
Indianapolis, Indiana, United States, 46202-2884
United States, Maryland
VA Maryland Health Care System, Baltimore
Baltimore, Maryland, United States, 21201
United States, Massachusetts
VA Medical Center, Jamaica Plain Campus
Boston, Massachusetts, United States, 02130
United States, Michigan
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48113
United States, Missouri
VA Medical Center, St Louis
St Louis, Missouri, United States, 63106
United States, New York
VA Western New York Healthcare System at Buffalo
Buffalo, New York, United States, 14215
United States, North Carolina
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27157-1053
United States, Ohio
VA Medical Center, Cleveland
Cleveland, Ohio, United States, 44106
United States, Oregon
VA Medical Center, Portland
Portland, Oregon, United States, 97201
United States, Pennsylvania
VA Pittsburgh Health Care System
Pittsburgh, Pennsylvania, United States, 15240
United States, Tennessee
VA Medical Center
Nashville, Tennessee, United States, 37212-2637
United States, Texas
VA North Texas Health Care System, Dallas
Dallas, Texas, United States, 75216
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, United States, 77030
United States, Virginia
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States, 23249
United States, Washington
VA Puget Sound Health Care System, Seattle
Seattle, Washington, United States, 98108
Sponsors and Collaborators
Investigators
Study Chair: Paul M. Palevsky VA Pittsburgh Health Care System
  More Information

Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00076219     History of Changes
Other Study ID Numbers: 530
Study First Received: January 15, 2004
Results First Received: June 12, 2013
Last Updated: August 16, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Acute Renal Failure
Renal Replacement Therapy
multi-site randomization trial
Hemodialysis
Hemofiltration
Critical Illness
Hemodiafiltration

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

ClinicalTrials.gov processed this record on October 20, 2014