Acute Renal Failure Trial Network (ATN) Study

Completed · Phase 3

Conditions studied: Acute Renal Failure

In brief

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.

Key facts

Study ID

NCT00076219

Run by

US Department of Veterans Affairs

People needed

1124

Starts

2003-10-01

Expected to finish

2008-07-01

Last updated by the study team

2013-08-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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:
• Fulfillment of the definition of ARF; and
• 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

Where it is running

• Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock — No. Little Rock, Arkansas, United States
• VA Medical Center, San Francisco — San Francisco, California, United States
• VA Greater Los Angeles Healthcare System, West LA — West Los Angeles, California, United States
• VA Eastern Colorado Health Care System, Denver — Denver, Colorado, United States
• VA Connecticut Health Care System (West Haven) — West Haven, Connecticut, United States
• VA Medical Center, Miami — Miami, Florida, United States
• VA Medical Center, Augusta — Augusta, Georgia, United States
• Richard Roudebush VA Medical Center, Indianapolis — Indianapolis, Indiana, United States
• VA Maryland Health Care System, Baltimore — Baltimore, Maryland, United States
• VA Medical Center, Jamaica Plain Campus — Boston, Massachusetts, United States
• VA Ann Arbor Healthcare System — Ann Arbor, Michigan, United States
• VA Medical Center, St Louis — St Louis, Missouri, United States
• VA Western New York Healthcare System at Buffalo — Buffalo, New York, United States
• Wake Forest University School of Medicine — Winston-Salem, North Carolina, United States
• VA Medical Center, Cleveland — Cleveland, Ohio, United States
• VA Medical Center, Portland — Portland, Oregon, United States
• VA Pittsburgh Health Care System — Pittsburgh, Pennsylvania, United States
• VA Medical Center — Nashville, Tennessee, United States
• VA North Texas Health Care System, Dallas — Dallas, Texas, United States
• Michael E. DeBakey VA Medical Center (152) — Houston, Texas, United States
• Hunter Holmes McGuire VA Medical Center — Richmond, Virginia, United States
• VA Puget Sound Health Care System, Seattle — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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