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

Study Overview
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Brief Summary
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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

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

Conditions
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Aortic Surgery, Acute Kidney Injury

Intervention / Treatment
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* Drug: Atorvastatin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: atrovastatin<br> | Drug: Atorvastatin<br>* 80 mg (PO) once daily for 6 days<br>|
| Placebo Comparator: placebo<br> | Drug: placebo<br>* 80 mg (PO) once daily for 6 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aortic surgery, postoperative acute kidney injury, statin, the patient undergoing aortic surgery