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

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02157337
• Other study ID #: 4-2013-0551
• Status: Completed
• Phase: Phase 4
• First received: June 3, 2014
• Last updated: January 23, 2017
• Start date: March 12, 2014
• Est. completion date: May 29, 2015

Study information

• Verified date: January 2017
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: May 29, 2015
• Est. primary completion date: May 29, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Aortic Surgery
• Wounds and Injuries

Intervention

Drug:
• Atorvastatin
80 mg (PO) once daily for 6 days
• placebo
80 mg (PO) once daily for 6 days

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum creatinine increase >3.0-fold from baseline OR serum creatinine =4.0 mg/dl with an acute increase of at least 0.5 mg/dl OR U/O <0.3 ml/kg/h for 24 h OR anuria for 12 h OR need for RRT		up to 7 days after the aortic surgery
Primary	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	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