NCT02157337

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

Completed Phase 4 Last updated 25 January 2017

What this trial tests

Phase 4 trial testing Atorvastatin in Aortic Surgery in 23 participants. Completed in 29 May 2015.

Timeline

12 March 2014

Primary endpoint
29 May 2015

29 May 2015

Quick facts

Lead sponsor	Yonsei University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	23
Start date	12 March 2014
Primary completion	29 May 2015
Estimated completion	29 May 2015
Sites	1 location across South Korea

Drugs / interventions tested

• Atorvastatin (atorvastatin) — full drug profile →
• placebo

Conditions studied

• Aortic Surgery — all drugs for Aortic Surgery →
• Acute Kidney Injury — all drugs for Acute Kidney Injury →

Sponsor

Yonsei University

Who can join

Adults 20 to 80, any sex, with Aortic Surgery or Acute Kidney Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.