Pediatric Out-of-Hospital Cardiac Arrest Resuscitation: Evaluation of IM Epinephrine (The PRIME Trial)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 284
- 试验地点
- 1
- 主要终点
- Time to initial return of spontaneous circulation (ROSC)
研究概览
简要总结
This is a pragmatic, two-arm, open-label, prospective stepped-wedge cluster quasi randomized control trial (SW-CRCT) looking to evaluate early intramuscular (IM) epinephrine in the management of pediatric out-of-hospital cardiac arrest (POHCA).
详细描述
IM epinephrine may provide a more efficient means of administering the initial epinephrine dose (versus IV/IO administration) to a child experiencing pediatric out of hospital cardiac arrest (POHCA) with no greater risk of harm. In so doing, this may improve the short- and long-term outcomes of these patients. There is an abundance of literature detailing the risk/benefit profile of IM epinephrine use in anaphylaxis; however, there is no human data on this topic as it relates to cardiac arrest. Important knowledge gaps include whether the use of IM epinephrine via autoinjector and/or pre-filled syringe leads to faster administration of the initial doses of epinephrine without delaying time to definitive epinephrine (via IV/IO) and the impact on time to initial and sustained return of spontaneous circulation (ROSC). This trial will be the first to examine the role of IM epinephrine via autoinjector/pre-filled syringe in POHCA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 1 day to and including 17 years experiencing an out-of-hospital cardiac arrest (OHCA)
- •Must be receiving at least 1 minute of CPR by trained first responders (police, fire, or paramedic services)
排除标准
- •Children who experience OHCA due to an obvious traumatic event.
研究组 & 干预措施
Intramuscular Epinephrine Dose
POHCA events will be handled per standard of care, however, first dose epinephrine administration will be via intramuscular (IM) autoinjector and/or pre-filled syringes. Dosing will be dependent on weight as follows:
- 3-<5kg=0.3mg IM epinephrine
- 5-<10kg=0.5mg IM epinephrine
- 10-<20kg=1.0mg IM epinephrine
- 20-<30kg=2.0mg IM epinephrine
- 30kg=3.0mg IM epinephrine
干预措施: Epinephrine Injection (Drug)
结局指标
主要结局
Time to initial return of spontaneous circulation (ROSC)
时间窗: At time of event
The primary outcome will be the time to initial ROSC. The investigator will compare time to initial ROSC between the standard of care and intervention periods.
次要结局
- Time to sustained ROSC(At time of event)
- Survival(From time of event to ED admission)
- Post POHCA survival(Dependent on survival at 6 and 12 month period post POHCA event)
- Neurological status(From time of discharge and 6 and 12 months post POHCA event)
- Return of spontaneous circulation(At time of event)
- Survival - comparison between both arms(From time of event to hospital admission)
- PCCU/Hospital length of stay(From time of hospital/PCCU admission to discharge, up to 1 year)
- Survival to hospital discharge(Dependent on course of hospital stay, up to 1 year)
- Life Impact and Pediatric Quality of Life assessments(6 and 12 months post POHCA event)
研究者
Janice Tijssen
MD MSc, Interim Director, Paediatric Critical Care
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's