The Effect of Atorvastatin on Prevention of Postoperative Acute Kidney Injury in Patients Undergoing Aortic Surgery

Yonsei University

Status and phase: Completed; Phase 4

Conditions: Acute Kidney Injury; Aortic Surgery

Treatments: Drug: placebo; Drug: Atorvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT02157337

4-2013-0551

Details and patient eligibility

About

Acute kidney injury(AKI) is a common and severe complication after the cardiac surgery. Postoperative AKI increases the in-hospital stay, intensive care unit(ICU) stay and postoperative mortality. Aortic surgery is the most risky surgery that causes the postoperative AKI, and the incidence of AKI after aortic surgery is about 50%.

Statin is a 3-hydroxy-3-methyl-glutaryl co-enzyme A (HMG CoA) reductase inhibitors and is used primarily to lower the level of plasma cholesterol. Apart from the antilipid effect, statin has pleiotropic effects include anti-inflammation, decrease of oxidative stress, recovery of endothelial cell injury and stabilization of thrombus.

The pathology of AKI after aortic surgery include not only hypoperfusion of renal blood flow but also thromboembolism, inflammatory reaction after use of cardiopulmonary bypass(CPB) and oxidative stress. Therefore, the incidence of AKI after aortic surgery can be expected to decrease after the perioperative use of statin because of the pleiotropic effects of it. The aim of this study is to examine the association between preoperative statin treatment and the incidence of postoperative acute kidney injury(AKI) in patients undergoing aortic surgery

Enrollment: 23 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. the patients undergoing aortic surgery
2. the age: 20~80 yrs

Exclusion criteria

1. taking the statin before the admission
2. having preoperative severe renal dysfunction (eGFR < 15 ml/min per 1.73 m2)
3. past history of liver disease OR serum AST/ALT increase > 2-fold from upper normal limit
4. past history of myopathy, myasthenia gravis, rhabdomyolysis OR increased creatinine kinase
5. drug or alcohol abuser
6. hypothyroidism
7. taking Macrolide, Azole antifungals, H2 antagonists, Cyclosporine, Omeprazole, Amiodarone, Fibrates and Niacin

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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23 participants in 2 patient groups, including a placebo group

atrovastatin

Experimental group

Treatment:

Drug: Atorvastatin

placebo

Placebo Comparator group

Treatment:

Drug: placebo