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

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

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury; Aortic Surgery
• Intervention / Treatment: Drug: Atorvastatin; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Department of anesthesiology and pain medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: placebo; 80 mg (PO) once daily for 6 days
Experimental: atrovastatin	Drug: Atorvastatin; 80 mg (PO) once daily for 6 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Other Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2014
• Primary Completion (Actual): May 29, 2015
• Study Completion (Actual): May 29, 2015

Study Registration Dates

• First Submitted: June 3, 2014
• First Submitted That Met QC Criteria: June 5, 2014
• First Posted (Estimate): June 6, 2014

Study Record Updates

• Last Update Posted (Estimate): January 25, 2017
• Last Update Submitted That Met QC Criteria: January 23, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: statin; aortic surgery; postoperative acute kidney injury; the patient undergoing aortic surgery
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Wounds and Injuries; Acute Kidney Injury; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin
• Other Study ID Numbers: 4-2013-0551