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

Phase 4

Completed

• Conditions: Aortic Surgery; Acute Kidney Injury
• Interventions: Drug: placebo; Drug: Atorvastatin

• Registration Number: NCT02157337
• Lead Sponsor: Yonsei University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-12
• Study First Submitted: 2014-06-03
• Study First Submitted QC: 2014-06-05
• Study First Posted: 2014-06-06
• Primary Completion: 2015-05-29
• Study Completion: 2015-05-29
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-23
• Last Update Posted: 2017-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	-
atrovastatin	Atorvastatin	-

Primary Outcome Measures

Name	Time	Method
Serum creatinine increase ≥0.3 mg/dl OR increase to 1.5-fold from baseline OR Urine output(U/O) < 0.5 ml/kg/h for 6 h	up to 7 days after the aortic surgery

Secondary Outcome Measures

Name	Time	Method
Serum creatinine increase >2.0-3.0-fold from baseline OR U/O < 0.5 ml/kg/h for 12 h	up to 7 days after the aortic surgery

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine; 🇰🇷 Seoul, Korea, Republic of