Clinical trial NCT02157337: The Effect of Atorvastatin on Prevention of Postoperative Acute Kidney Injury in Patients Undergoing Aortic Surgery
Official title: The Effect of Atorvastatin on Prevention of Postoperative Acute Kidney Injury in Patients Undergoing Aortic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Aortic Surgery
Acute Kidney Injury
Keywords: aortic surgery
postoperative acute kidney injury
statin
the patient undergoing aortic surgery
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-06-06
Enrollment: 23
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: up to 7 days after the aortic surgery
Secondary outcomes:
measure: Serum creatinine increase >2.0-3.0-fold from baseline OR U/O < 0.5 ml/kg/h for 12 h
timeFrame: up to 7 days after the aortic surgery
Other outcomes:
measure: 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
timeFrame: up to 7 days after the aortic surgery
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine
Study officials:
References: