Acute Kidney Injury, Aortic Surgery
Conditions
Keywords
aortic surgery, postoperative acute kidney injury, statin, the patient undergoing aortic surgery
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
Interventions
DRUGAtorvastatin
80 mg (PO) once daily for 6 days
DRUGplacebo
80 mg (PO) once daily for 6 days
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| 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
| 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
| 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 |
Countries
South Korea
Outcome results
None listed