NCT01595958已完成3 期
CYclosporine A in Non-shockable Out-of-hospital Cardiac Arrest ResUScitation
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 796
- 试验地点
- 1
- 主要终点
- Sequential Organ Failure Assessment score (SOFA)
研究概览
简要总结
The investigators hypothesised that cyclosporine A administration at the onset of cardiopulmonary resuscitation, by inhibiting the mitochondrial permeability transition pore, could prevent the post cardiac arrest syndrome and improve outcomes.
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
- Single (Outcomes Assessor)
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
- •Witnessed out-of-hospital cardiac arrest
- •Non shockable cardiac rhythm
排除标准
- •Evidence of trauma
- •Evidence of pregnancy
- •Duration of no flow more than 30 minutes
- •Rapidly fatal underlying disease
- •Allergy to cyclosporin A
研究组 & 干预措施
Cyclosporine A
Experimental
Single intravenous bolus of cyclosporine A (2.5 mg/kg) at the onset of resuscitation
干预措施: Cyclosporine A (Drug)
Cyclosporine A
Experimental
Single intravenous bolus of cyclosporine A (2.5 mg/kg) at the onset of resuscitation
干预措施: cardio-pulmonary resuscitation (Procedure)
Control
Active Comparator
usual care of cardiac arrest
干预措施: cardio-pulmonary resuscitation (Procedure)
结局指标
主要结局
Sequential Organ Failure Assessment score (SOFA)
时间窗: At 24 hours after hospital admission
次要结局
- Hospital admission with return of spontaneous circulation(At 24 hours following admission, at day 28, at hospital discharge (an average time frame of 7 days))
- Survival(At 24 hours following admission, at day 28, and at hospital discharge (an average time frame of 7 days))
- Good cerebral outcome(At 24 hours following admission, at day 28, and at hospital discharge (an average time frame of 7 days))
- All adverse events(until hospital discharge (an average time frame of 7 days))
研究者
研究点 (1)
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