Prophylactic Amiodarone for Shockable Cardiac Arrest During Targeted Post Cardiac Arrest Care: Multi-center, Open Labelled Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 302
- 试验地点
- 1
- 主要终点
- Number of patients with re-arrest by shockable rhythm
研究概览
简要总结
The aim of this study is to determine whether the prophylactic amiodarone can prevent re-arrest with ventricular shockable rhythm in patients who treated with targeted temperature management after return of spontaneous circulation from cardiac arrest which had been shockable rhythm during CPR.
详细描述
Patients with cardiac arrest are in high risk of re-arrest during post cardiac arrest care due to vulnerable heart state electrically and hemodynamically. Especially if patients who had experienced shockable rhythms such as ventricular fibrillation or pulseless ventricular tachycardia during CPR, then they are at high risk of developing shockable re-arrest.
However until now there has not been any evidence of prophylactic anti arrhythmic drug effect during post cardiac arrest care.
Amiodarone is class III anti arrhythmic drug which has been used for conversion of ventricular arrhythmia during CPR.
In this study we want to determine whether the prophylactic amiodarone can prevent re-arrest with ventricular shockable rhythm or not.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non traumatic cardiac arrest patients who had VF or pVT during CPR in ER
排除标准
- •age < 18 yr
- •pregnancy
- •non cardiac caused arrest such as hanging
- •previous amiodarone continuous infusion before radomization
- •sustained ventricular arrhythmia recurrence after ROSC
- •extracorporeal membrane oxygenation
- •contra indication for amiodarone
- •disagree with this research
研究组 & 干预措施
Prophylactic amiodarone
干预措施: Amiodarone Injection (Drug)
结局指标
主要结局
Number of patients with re-arrest by shockable rhythm
时间窗: 5 days from return of spontaneous circulation
No recurrence of ventricular fibrillation or pulseless ventricular tachycardia
次要结局
未报告次要终点
研究者
Won Young Kim
Professor
Asan Medical Center