Single Center Randomized Clinical Trial of the Effects of Acetylcysteine in the Prevention of Postoperative Renal Failure
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Rise in creatinine above baseline
研究概览
简要总结
The purpose of this study is to determine if Acetylcysteine is effective in preventing renal failure associated with cardiac surgery
详细描述
Postoperative renal dysfunction is a predictor of significant morbidity and mortality among patients undergoing cardiac surgery. The mortality associated with coronary artery by-pass surgery increases from 2% to almost 19% in patients with renal failure and approaches 60% in patients who require hemodialysis. Patients with preoperative renal dysfunction referred for coronary artery by pass surgery have an extraordinarily high risk of requiring postoperative dialysis. For example, among those patients with preoperative creatinine >2.5 mg/dL, almost 50% require hemodialysis.
Comparison: N-Acetylcysteine is superior to placebo in preventing renal failure after cardiac surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pts with baseline chronic kidney disease (eGFR<60 ml/min/1.73m2)undergoing cardiac surgery
排除标准
- •Patients on hemodialysis preoperatively
- •IV contrast within 4 days prior to surgery
- •Urgent/emergent surgery
- •History of renal transplantation
结局指标
主要结局
Rise in creatinine above baseline
时间窗: 7 days postoperatively
次要结局
- Creatinine increase >25% or =/> 0.5 mg/dl above baseline(Postoperative days 5, 7 and 30)
- Length of stay in the ICU and the hospital
- Operative mortality(30-day)