Prophylactic Anti-aRrhythmic Therapy With Amiodarone in Critically Ill Patients Admitted for an Out-of-hospital Cardiac Arrest With Initial Shockable Rhythm.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 674
- 试验地点
- 29
- 主要终点
- Rate of Mortality and severe ventricular arrhythmia
研究概览
简要总结
To 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)
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
- •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)
- •Indication for amiodarone decided by the physician at ICU admission
- •No central venous catheter available for continuous infusion of amidoarone
- •Thyroid disease under treatment
- •History of cardiac conduction disorders, not treated by permanent pacemaker
- •Any contra indication to amiodarone treatment
- •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
- •Moribund patient due to pre-arrest history (estimated life expectancy < 3 months)
- •Pregnant or breastfeeding women
- •Patient needing a nadolol treatment due to QT long syndrome or catecholaminergic polymorphic ventricular tachycardia
- •Patient with known pulmonary fibrosis
- •Patient with known interstitial lung disease
研究组 & 干预措施
Amiodarone
Initial loading dose of 300mg over 30 minutes in 250ml of glucose 5% solution. Continuous amiodarone infusion will be administered for 72 hours at a dose of 10 mg/kg without exceeding 900 mg/24h.
干预措施: Amiodarone (Drug)
结局指标
主要结局
Rate of Mortality and severe ventricular arrhythmia
时间窗: 30 days
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
- outcomes related with cardiac events(90 days)
- outcomes related with mortality(90 days)
- Duration of invasive mechanical ventilation(90 days)
- Number of participants with outcomes related with amiodorane side effects(5 days)
- Neurological outcome(90 days)
- Duration vasopressor infusion(90 days)
- Length of ICU stay(90 days)
- Length of stay in hospital(90 days)
- Dose of the anti-arrhythmic drugs(90 days)
- Number of days of anti-arrhythmic drugs(90 days)
研究者
Hugo Bellut
Investigator coordonator
Versailles Hospital