Phase 3
N=1,124
Acute Renal Failure Trial Network (ATN) Study
Acute Renal Failure
Bottom Line
View on ClinicalTrials.gov: NCT00076219 ↗Enrolled (actual)
1,124
Serious AEs
50.4%
Results posted
Aug 2013
Primary outcome: Primary: 60-day All-cause Mortality — 302; 289 participants — p=0.47
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- renal replacement therapy (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Sep 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 60-day All-cause Mortality |
302; 289 | 0.47 |
Summary
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.
Eligibility 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:
- 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
Data sourced from ClinicalTrials.gov (NCT00076219). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.