The Effect of Atorvastatin on Prevention of Postoperative Acute Kidney Injury in Patients Undergoing Aortic Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the patients undergoing aortic surgery
- •the age: 20~80 yrs
排除标准
- •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
研究组 & 干预措施
atrovastatin
干预措施: Atorvastatin (Drug)
placebo
干预措施: placebo (Drug)
结局指标
主要结局
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
时间窗: up to 7 days after the aortic surgery
次要结局
- 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)