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

Sponsor

Yonsei University (Other)

Overall Status

Completed

CT.gov ID

NCT02157337

Collaborator

(none)

Enrollment

Location

Arms

14.6

Actual Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Aortic Surgery Acute Kidney Injury	Drug: Atorvastatin Drug: placebo	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

23 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Mar 12, 2014

Actual Primary Completion Date :

May 29, 2015

Actual Study Completion Date :

May 29, 2015

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: atrovastatin

Drug: Atorvastatin

80 mg (PO) once daily for 6 days

Placebo Comparator: placebo

Drug: placebo

80 mg (PO) once daily for 6 days

Outcome Measures

Primary Outcome Measures

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

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

the patients undergoing aortic surgery
the age: 20~80 yrs

Exclusion Criteria:

taking the statin before the admission
having preoperative severe renal dysfunction (eGFR < 15 ml/min per 1.73 m2)
past history of liver disease OR serum AST/ALT increase > 2-fold from upper normal limit
past history of myopathy, myasthenia gravis, rhabdomyolysis OR increased creatinine kinase
drug or alcohol abuser
hypothyroidism
taking Macrolide, Azole antifungals, H2 antagonists, Cyclosporine, Omeprazole, Amiodarone, Fibrates and Niacin