NCT04028024Unknown不适用
Study on the Protective Effect of Inhibiting Systemic Inflammatory Response in Patients Undergoing Cardiac Surgery.
Shanghai Zhongshan Hospital0 个研究点目标入组 90 人开始时间: 2019年8月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 主要终点
- postoperative delirium
研究概览
简要总结
The purpose of the study was to verify the protective effect of inhibiting systemic inflammatory response in patients undergoing cardiac surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subject needs to have valve surgery
- •subject needs to have coronary artery bypass grafting surgery
- •subject needs to have artificial blood vessel replacement surgery
- •ASA(American Society of Anesthesiologists) score II~III
- •NYHA(New York Heart Association) II~III
排除标准
- •LVEF(left ventricular ejection fraction) <40% measured by echocardiogram
- •history of myocardial infarction within 1 month
- •history of serious pulmonary infection or endocarditis within 3 months
- •history of important surgery within 6 months
研究组 & 干预措施
inhibiting systemic inflammatory response
Other
Ulinastatin 5000U/kg in 20ml NS i.v. before occlusion of aorta
干预措施: Ulinastatin (Drug)
结局指标
主要结局
postoperative delirium
时间窗: 7 days postoperatively or discharge, whichever came first
the incidence of postoperative delirium
postoperative renal insufficiency
时间窗: 7 days postoperatively or discharge, whichever came first
the incidence of renal insufficiency
次要结局
未报告次要终点
研究者
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