NCT01909739已完成不适用
The Effects of Statin on Postoperative Renal Function in Valvular Heart Surgery: a Randomized, Placebo-controlled Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Comparison of postoperative renal function with or without statin in patients undergoing valvular heart surgery
研究概览
简要总结
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 valvular heart 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients over the age of 20 scheduled for valvular heart surgery
排除标准
- •Current statin use
- •Left ventricular ejection fraction < 30%
- •Preexisting congestive heart failure
- •Severe coronary artery disease
- •Hemodynamically unstable arrhythmia
- •Cardiogenic shock during perioperative period
- •Ventricular assist device
- •Severe renal dysfunction (eGFR < 15 ml/min per 1.73 m2)
- •History of liver disease or elevated serum transaminases
- •History of rhabdomyolysis or elevated creatinine kinase
研究组 & 干预措施
Statin group
Experimental
干预措施: atrovastatin (Drug)
Placebo group
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Comparison of postoperative renal function with or without statin in patients undergoing valvular heart surgery
时间窗: renal function change from 24-hour after surgery to 120-hour after surery
BUN/Cr cystatin C eGFR urine output incidence of acute kidney injury(based on the AKIN criteria)
次要结局
未报告次要终点
研究者
研究点 (1)
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