Prophylactic Anti-aRrhythmic therapy with Amiodarone in critically ill patients admitted for an out-of-hospital Cardiac Arrest with initial shockable rhythm._PARACA
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 674
- 试验地点
- 27
- 主要终点
- The primary endpoint is a composite of 30-day (starting from inclusion) all-cause mortality and occurrence of severe in-hospital ventricular arrhythmia, defined by ventricular fibrillation and/or ventricular tachycardia requiring intervention occurring between inclusion and hospital discharge (or 30-day whichever the sooner).
研究概览
简要总结
To comparatively determine if prophylactic administration of amiodarone for 72 hours in critically ill patients admitted after an OHCA with shockable rhythm, with a confirmed or a presumed cardiac cause, decreases the incidence of a composite endpoint of 30-day (starting from inclusion) all-cause mortality and/or severe in-hospital ventricular arrhythmia recurrence (ventricular fibrillation and/or ventricular tachycardia requiring intervention including re-arrest)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Patient aged ≥ 18 years
- •Admitted in intensive care unit
- •Out-of-hospital cardiac arrest with initial shockable rhythm
- •Presumed cardiac or unknown cause
- •Delay between ROSC and screening for randomisation < 6 hours
- •Informed consent from the patient or a surrogate or deferred consent
- •Affiliated to or benefiting from a social insurance
排除标准
- •Cardiac arrest secondary to an extra-cardiac cause (suspected or confirmed)
- •Moribund patient due to pre-arrest history (estimated life expectancy < 3 months)
- •Pregnant or breastfeeding women
- •Indication for amiodarone decided by the physician at ICU admission
- •No central venous catheter available for continuous infusion of amiodarone
- •History of thyroid disease (except for stable, uncomplicated hypothyroidism)
- •History of cardiac conduction disorders, not treated by permanent pacemaker
- •Amiodarone allergy
- •Refractory ventricular arrhythmia or electrical storm
- •Need for veno-arterial extracorporeal membrane oxygenation (VA-ECMO) at admission
- •Known limitations in therapy and Do Not Resuscitate-order
结局指标
主要结局
The primary endpoint is a composite of 30-day (starting from inclusion) all-cause mortality and occurrence of severe in-hospital ventricular arrhythmia, defined by ventricular fibrillation and/or ventricular tachycardia requiring intervention occurring between inclusion and hospital discharge (or 30-day whichever the sooner).
The primary endpoint is a composite of 30-day (starting from inclusion) all-cause mortality and occurrence of severe in-hospital ventricular arrhythmia, defined by ventricular fibrillation and/or ventricular tachycardia requiring intervention occurring between inclusion and hospital discharge (or 30-day whichever the sooner).
次要结局
未报告次要终点
研究者
Project Manager
Scientific
Centre Hospitalier De Versailles