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

NCT ID: NCT02157337

Last Updated: 2017-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-12
• Study Completion Date: 2015-05-29

Brief Summary

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

Conditions

Aortic Surgery; Acute Kidney Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

atrovastatin

Group Type: EXPERIMENTAL

Atorvastatin

Intervention Type: DRUG

80 mg (PO) once daily for 6 days

placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

80 mg (PO) once daily for 6 days

Interventions

Atorvastatin

80 mg (PO) once daily for 6 days

Intervention Type: DRUG

placebo

80 mg (PO) once daily for 6 days

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Anesthesiology and Pain Medicine

Seoul, Seoul, South Korea

Countries

South Korea

Other Identifiers

4-2013-0551

Identifier Type: -

Identifier Source: org_study_id