NCT01394419已完成4 期
Effect of N-acetylcysteine on Prevention of Acute Kidney Injury in High Risk Patients Undergoing Off-pump Coronary Artery Bypass Graft
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Incidence of acute kidney injury
研究概览
简要总结
N-acetylcysteine may prevent acute kidney injury in high risk patients undergoing off-pump coronary artery bypass graft.
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
- Double (Participant, 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 undergoing off-pump coronary artery bypass surgery and meets more than one of the following criteria;
- •preoperative serum creatinine > 1.4 mg/dl
- •Age > 70 years
- •Diabetes mellitus
- •left ventricular ejection fraction < 35 % or congestive heart failure (NYHA III or IV)
- •emergency surgery or re-operation
排除标准
- •preoperative acute renal failure, patients on dialysis, use of N-acetylcystein within 5 days of surgery, history of hypersensitivity to N-acetylcystein
研究组 & 干预措施
NAC group
Experimental
N-acetylcysteine
干预措施: N-acetylcysteine (Drug)
Placebo group
Placebo Comparator
Saline
干预措施: Saline (Drug)
结局指标
主要结局
Incidence of acute kidney injury
时间窗: within 5 days after surgery
次要结局
未报告次要终点
研究者
研究点 (1)
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