NCT01384643已完成4 期
Effect of Propofol on Renal Injury in Patients Undergoing Valvular Heart Surgery: A Prospective, Randomized Controlled Trial
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
- 112
- 试验地点
- 1
- 主要终点
- Serum creatinine
研究概览
简要总结
Ischemia/reperfusion (I/R)-induced acute kidney injury is a serious complication affecting patient outcome following cardiovascular surgeries. Propofol, an intravenously administered anesthetic with antioxidant properties, protects organs from I/R injury. This study aimed to investigate the ability of propofol to protect kidneys against I/R injury in the 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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing valvular heart surgery.
- •Age: 20~75.
排除标准
- •Emergency operation.
- •Patients with vitamin E or vitamin C within 5 days before surgery.
- •Patients with preoperative C-reactive protein (CRP) > 16 mg/L.
- •Patients with serum creatinine ≥ 2.0 mg/dL
- •Patients under hemodialysis.
- •Patients with acute myocardial infarction within 1 week before surgery
研究组 & 干预措施
Propofol group
Experimental
干预措施: Propofol (Drug)
Control group
Placebo Comparator
干预措施: Propofol (Drug)
结局指标
主要结局
Serum creatinine
时间窗: incidence of AKI during 48 hours after the surgery incidence of AKI
Comparison of serum creatinine elevation after surgery between Propofol and Control group.
次要结局
未报告次要终点
研究者
研究点 (1)
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