At a glance
ClinicalIndex Comparison Record- ✓Acute renal failure clinically consistent with acute tubular necrosis
- ✓Plan for renal replacement therapy
- ✓Receiving care in a critical care unit
- ✓At least one non-renal organ failure or sepsis present
- ✕Baseline serum creatinine >2 mg/dL in males or >1.5 mg/dL in females (pre-existing renal disease)
- ✕Acute renal failure due to etiology other than acute tubular necrosis
- ✕More than 72 hours since meeting ARF criteria and BUN >100 mg/dL simultaneously
- ✕Prior kidney transplant
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
CSP #530 - Intensive vs. Conventional Renal Support in Acute Renal Failure
In Brief
A Phase 3 clinical trial evaluating renal replacement therapy for Acute Renal Failure. Completed, enrolled 1,124 participants across 22 sites.
Detailed 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.
Study Details
Timeline
Interventions
renal replacement therapy