2024-516864-27-00招募中2 期
CardioPulmonary resuscitation with Argon (CPAr) trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 10
- 主要终点
- 48 h Serum Neuron Specific Enolase (NSE) concentration for evaluation of Ar activity on neuronal preservation.
研究概览
简要总结
The objective of the CPAr trial is to evaluate the efficacy in reducing post-CA neurological injury of Ar 70%/O2 30% ventilation in patients resuscitated from OHCA with an experimental ventilator, specifically modified to permit Ar/O2 ventilation.
研究设计
- 分配方式
- Randomized
- 主要目的
- CardioPulmonary resuscitation with Argon (CPAr) trial
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •witnessed non-traumatic OHCA of presumably cardiac etiology with a presenting shockable rhythm
- •age ≥ 18 years
- •unconsciousness after return of spontaneous circulation (ROSC)
- •duration of CPR ≤ 40 mins
- •Initiation of study intervention ≤ 4 hrs from ROSC
- •stable SaO2 ≥ 94% (according to the physician’s criteria), with a FiO2 of 30%
排除标准
- •age < 18 years
- •initiation of the study intervention > 4 hrs from ROSC
- •participation to another clinical trial
- •non-witnessed CA
- •CA of traumatic origin
- •non-presumably cardiac cause
- •non-shockable presenting rhythm (pulseless electrical activity and asystole)
- •women of childbearing potential defined as younger of 50 years
- •known terminal illness
- •pre-CA cerebral performance category (CPC) ≥ 3
结局指标
主要结局
48 h Serum Neuron Specific Enolase (NSE) concentration for evaluation of Ar activity on neuronal preservation.
48 h Serum Neuron Specific Enolase (NSE) concentration for evaluation of Ar activity on neuronal preservation.
次要结局
- hs-cTnT plasma concentration for evaluation of Ar activity on myocardial preservation;
- Brain imaging (MRI with DWI and DTI, in patients that remain comatose), for evaluation of Ar activity on neuronal preservation;
- Multiorgan function (circulating biomarkers);
- Survival and CPC score up to 6 months, for evaluation of functional outcome.
研究者
Roberto Latini
Scientific
Istituto Di Ricerche Farmacologiche Mario Negri
研究点 (10)
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