drugset / Trial / NCT00791648

Short-term Atorvastatin's Effect on Acute Kidney Injury Following Cardiac Surgery

NCT00791648

Completed 653 enrolled Vanderbilt University Medical Center
RandomizedParallel-groupQuadruple-blindPrevention

Summary

Aim1a: Statin naive patient's scheduled for cardiac surgery will be randomized to 80mg atorvastatin or placebo on the day prior to surgery and then 40mg daily thereafter until hospital discharge to test the hypothesis that short-term atorvastatin use decreases: 1. acute kidney injury following cardiac surgery. 2. postoperative delirium following cardiac surgery. Aim1b: Patients using statins preoperatively will be randomized to atorvastatin 80mg or placebo on day of surgery and 40mg or placebo on postop day 1 with resumption of preoperative statin therapy on postop day 2 to test the hypothesis that short-term atorvastatin use decreases: 1. acute kidney injury following cardiac surgery. 2. postoperative delirium following cardiac surgery. Endpoints include glomerular filtration, urine and plasma markers of renal dysfunction, markers of oxidative stress, mitochondrial function, systemic inflammatory markers, delirium, dialysis, stroke, myocardial infarction, time to extubation, ICU length of stay, and death.

Timeline

Start
2009-07
Primary completion
2014-10
Completion
2014-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Atorvastatin Small molecule 40 mg