Intra-arrest Therapeutic Hypothermia in Prehospital Cardiac Arrest. Impact on Biomarker of Brain Damage.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 244
- 试验地点
- 2
- 主要终点
- Prove efficacy of early induced hypothermia during ischemia in pre hospital cardiac arrest by a reduction of brain damage biomarkers.
研究概览
简要总结
The aim is to precise the place of therapeutic hypothermia induced before Return of Spontaneous Circulation (ROSC) in pre hospital cardiac arrest. If we find a benefit in terms of biomarkers in inducing in early hypothermia compared to hypothermia induced only after arrival at the hospital, there will be arguments to develop a higher scale study, allowing to prove benefits in terms of survival and neurological status.
详细描述
Principal aim : prove the efficiency of early therapeutic hypothermia induced during ischemia in pre hospital cardiac arrest by a reduction of brain damage biomarkers.
Secondary aim: prove the efficiency of early therapeutic induced hypothermia in the reduction of pro-inflammatory cytokines secretion. Determine the number of ROSC, patients survival, neurological status 48 hours after cardiac arrest (GCS) and when leaving the hospital, impact following initial cardiac rhythm and the cooling rate of early therapeutic induced hypothermia.
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
- •pre hospital cardiac arrest
排除标准
- •under 18 years old
- •pregnancy or breastfeeding women
- •patient under guardianship.
- •not beneficing a social health care system.
- •cardiac arrest of traumatic origin
- •patients with an initial body temperature under 34° C
- •cardiac arrests for which resuscitation maneuvers seem unjustified (DNR criteria)
结局指标
主要结局
Prove efficacy of early induced hypothermia during ischemia in pre hospital cardiac arrest by a reduction of brain damage biomarkers.
时间窗: 72 hours
次要结局
- Prove the efficacy of early therapeutic induced hypothermia in the reduction of pro-inflammatory cytokines secretion.(72 hours)
- Determine the number of Return of Spontaneous Circulation (ROSC), patients survival.(72 hours)
- Determine neurological status 48 hours after cardiac arrest (GCS)(48 hours)
- Determine impact following initial cardiac rhythm.(72 hours)
- Determine the cooling rate of early therapeutic induced hypothermia.(72 hours)
- Determine neurological status when leaving hospital (or 28 days if not applicable) (CPC)(28 days)