Short-term Atorvastatin's Effect on Acute Kidney Injury Following Cardiac Surgery
Completed · Not applicable · Has a placebo group
Conditions studied: Acute Kidney Injury, Post-Operative Delirium, Icu Delirium, Acute Renal Failure, Delirium
In brief
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.
Key facts
- Study ID
- NCT00791648
- Run by
- Vanderbilt University Medical Center
- People needed
- 653
- Starts
- 2009-07-01
- Expected to finish
- 2014-12-01
- Last updated by the study team
- 2019-09-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- open heart surgery
You may not qualify if…
- acute coronary syndrome with troponin leak or unrelenting angina
- liver dysfunction (transaminases 2x normal)
- history of myopathy or liver dysfunction on prior statin therapy
- use of potent CYP3A4 inhibitors such as antifungal azoles, macrolide antibiotics, HIV protease inhibitors, and nefazodone.
- pregnancy or breast feeding
- cyclosporine use
- dialysis
- history of kidney transplant
- fibrate users who cannot stop fibrate use.
Where it is running
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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