CYclosporine A in Shockable Out-of-hospital Cardiac Arrest ResUScitation
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Combined incidence of all-cause mortality and irreversible brain damage status
研究概览
简要总结
Cardiac arrest (CA) is a public health problem in industrialized countries. The prognosis of these patients remains poor with significant mortality and severe neurological sequelae in survivors.
The objective of the present study is to determine whether cyclosporine can improve patient clinical outcome after shockable CA. 520 patients with CA will be entered into a multicentre, randomized, placebo-controlled study. They will receive one single injection of cyclosporine (or placebo) prior to resuscitation. The incidence of the combined endpoint (mortality, irreversible brain damage informations such as bilateral abolition of N20 wave or absent motor response or extension to the nociceptive stimulation...) will be assessed 7 days after CA.
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 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
- •Shockable cardiac rhythm at first medical contact (ventricular fibrillation, ventricular tachycardia)
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
Single intravenous bolus of cyclosporine A (2.5 mg/kg) at the onset of resuscitation
干预措施: Single intravenous bolus of cyclosporine A (2.5 mg/kg) at the onset of resuscitation (Drug)
Control
Single intravenous bolus of placebo (2.5 mg/kg) at the onset of resuscitation
干预措施: Single intravenous bolus of placebo at the onset of resuscitation (Drug)
结局指标
主要结局
Combined incidence of all-cause mortality and irreversible brain damage status
时间窗: 7 days
the presence of irreversible brain damage is defined by the bilateral abolition of the N20 wave on somatosensory evoked potentials recordings or the absence of motor response or extension to painful stimuli on the Glasgow Coma Scale.
次要结局
未报告次要终点