Short-term Atorvastatin's Effect on Acute Kidney Injury Following Cardiac Surgery
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Hospital, Neurology, Psychiatric |
| Therapuetic Areas: | Nephrology / Urology, Neurology, Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/23/2017 |
| Start Date: | July 2009 |
| End Date: | December 2014 |
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.
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.
Inclusion Criteria:
- open heart surgery
Exclusion Criteria:
- 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.
We found this trial at
1
site
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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