Impact of Low Dose Epinephrine in the Management of Out-of-hospital Cardiac Arrest on Neurological Outcome: A Multicenter Randomized and Double-blind Trial.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 4,336
- 试验地点
- 26
- 主要终点
- Modified Rankin Scale (mRS) score
研究概览
简要总结
This study will test whether a lower dose of epinephrine (0.5 mg) given during emergency treatment for out-of-hospital cardiac arrest helps more patients survive with good brain function, compared to the standard dose (1 mg). Adults who experience cardiac arrest outside the hospital and are treated by emergency medical teams will be randomly assigned to receive either the low dose or the standard dose of epinephrine. The study will compare survival and neurological outcomes between the two groups over 28 days.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or female, aged ≥18 years. Out-of-hospital cardiac arrest for which resuscitation is decided by the SMUR team.
- •Medical Out-of-hospital cardiac arrest. Affiliated with or beneficiary of a social security plan
排除标准
- •Non-medical Out-of-hospital cardiac arrest (traumatic, drownings, electrocution, asphyxia, overdose, unknown cause).
- •Out-of-hospital cardiac arrest without advanced life support (Do Not Attempt Resuscitation order, body finding, the decision not to attempt advanced life support is at the physician's discretion).
- •Pregnant women, birthing or breastfeeding mothers
- •Adults under legal protection measure (such as guardianship, conservatorship)
- •Individuals deprived of liberty due to judicial or administrative decision
研究组 & 干预措施
Epinephrine 0.5 mg intravenous bolus every 3-5 minutes during Cardio-Pulmonary Resuscitation
Epinephrine 0.5 mg intravenous bolus every 3-5 minutes during Cardio-Pulmonary Resuscitation
干预措施: Epinephrine 0.5 mg intravenous bolus (Drug)
Epinephrine 1 mg IV bolus every 3-5 minutes during Cardio-Pulmonary Resuscitation
Epinephrine 1 mg intravenous bolus every 3-5 minutes during Cardio-Pulmonary Resuscitation
干预措施: Epinephrine 1 mg intravenous bolus (Drug)
结局指标
主要结局
Modified Rankin Scale (mRS) score
时间窗: 28-day
The mRS score is a validated score measuring neurologic outcomes after cardio-pulmonary resuscitation (CPR) : * mRS 0. No symptoms. * mRS 1. No significant disability. Able to perform all usual activities, despite some symptoms. * mRS 2. Slight disability. Independent but unable to perform usual activities (work, sports, leisure). mRS 3. Moderate disability. Requires assistance, but able to walk alone. * mRS 4. Moderately severe disability. Walking assistance and daily living activities not possible. mRS 5. Major disability. Bedridden, incontinent and requires constant nursing care and attention. * mRS 6. Death.
次要结局
- Vital status(Periprocedural period of cardiopulmonary resuscitation)
- vital status(28 days post-cardiac arrest)
- Modified Rankin Scale (mRS) score.(28 days post-cardiac arrest)
- Return of Spontaneous Circulation (ROSC).(Periprocedural period of cardiopulmonary resuscitation)
研究者
CHOUIHED Tahar
Coordinating Investigator
Central Hospital, Nancy, France