Early Amiodarone in Shockable Cardiac Arrest (Early-Amio) Study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 585
- 试验地点
- 1
- 主要终点
- Time from emergency medical services (EMS) arrival on-scene (or time of arrest if witnessed by EMS) to the administration of the initial dose of amiodarone in minutes
研究概览
简要总结
The primary objective of this pilot, pragmatic stepped-wedge cluster randomized trial is to evaluate if a modified cardiac arrest treatment algorithm calling for the administration of the initial amiodarone dose one 2-minute cycle earlier than current guidelines (during the same cycle as the initial dose of epinephrine) improves the time to amiodarone delivery in those with out-of-hospital cardiac arrest due to refractory ventricular fibrillation or ventricular tachycardia compared to usual care.
详细描述
The primary objective of this pilot, pragmatic stepped-wedge cluster randomized trial is to evaluate if a modified cardiac arrest treatment algorithm calling for the administration of the initial amiodarone dose one 2-minute cycle earlier than current guidelines (during the same cycle as the initial dose of epinephrine) improves the time to amiodarone delivery in those with out-of-hospital cardiac arrest due to refractory ventricular fibrillation or ventricular tachycardia compared to usual care.
The null hypothesis is that there is no difference in time to amiodarone delivery, relative to emergency medical services (EMS) arrival on-scene or time of arrest if witnessed by EMS, in the modified protocol calling for earlier amiodarone administration compared to usual care.
Evaluated secondary outcomes will include the proportion of patients receiving amiodarone before their third defibrillation, pulses present at emergency department arrival, survival to hospital discharge, neurologically intact survival at hospital discharge, timing to other critical EMS interventions, and clinical adverse events.
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
- 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
- •Emergency medical services (EMS)-treated non-traumatic out-of-hospital cardiac arrest
- •Initial rhythm on EMS rhythm assessment of ventricular fibrillation or ventricular tachycardia
- •Recurrence or persistence of ventricular fibrillation or ventricular tachycardia after one defibrillation attempt
排除标准
- •Known allergy to amiodarone
- •EMS-assessed contraindication to amiodarone
- •Pre-existing "do-not-attempt-resuscitation" orders
- •Inter-facility transportations
- •Initial care by a non-participating EMS agency able to perform advanced life support interventions
- •Pediatric patient as determined by EMS
- •Prisoners
- •Pregnant patients
研究组 & 干预措施
Early Amiodarone Protocol
Amiodarone administration after the second defibrillator shock, during the same two-minute cycle as the initial dose of epinephrine.
干预措施: Amiodarone Hydrochloride Injection (Drug)
Usual Care Protocol
Amiodarone administration after the third defibrillator shock, one two-minute cycle after the initial dose of epinephrine.
干预措施: Usual Care Protocol (Other)
结局指标
主要结局
Time from emergency medical services (EMS) arrival on-scene (or time of arrest if witnessed by EMS) to the administration of the initial dose of amiodarone in minutes
时间窗: up to 1 day
次要结局
- The number and proportion of patients receiving the initial dose of amiodarone from emergency medical services before the third shock from a defibrillator(up to 1 day)
- The number and proportion of patients with pulses present and documented by emergency medical services at the time of patient care transfer to hospital staff at emergency department arrival(up to 1 day)
- The number and proportion of patients surviving to be admitted to inpatient services after arrival to the emergency department(up to 1 day)
- The number and proportion of patients surviving to be discharged from the hospital (or 30 days, whichever is sooner) after their admission for cardiac arrest(up to 30 days)
- The number and proportion of patients surviving to be discharged from the hospital (or 30 days, whichever is sooner) after their admission for cardiac arrest with a Cerebral Performance Category score of 1 or 2(up to 30 days)
- Time from emergency medical services (EMS) arrival on-scene (or time of arrest if witnessed by EMS) to the delivery of other critical interventions in minutes(up to 1 day)
- Number and proportion of participants with adverse events(up to 1 day)
研究者
Joshua Lupton
Principal Investigator
Oregon Health and Science University