XePOHCAS - Xenon by Inhalation for Post Out of Hospital Cardiac Arrest Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,436
- 试验地点
- 10
- 主要终点
- functional outcome: degree of functional independence measured using a modified Rankin Scale (mRS)
研究概览
简要总结
XePOHCAS: Prospective, randomized, multicenter interventional trial in adult subjects with out-of-hospital cardiac arrest comparing treatment with standard-of-care post-cardiac arrest intensive care (which is targeted temperature management [TTM]) to xenon by inhalation plus standard-of-care post-cardiac arrest intensive care (including TTM).
详细描述
XePOHCAS:
Primary Objective:
To evaluate whether there is a difference in functional outcome with xenon 50% and oxygen during targeted temperature management (TTM) compared with similar oxygen content in air during TTM in comatose subjects with sustained restoration of spontaneous circulation (ROSC) within 30 minutes after out-of-hospital cardiac arrest (OHCA).
Secondary Objective:
To evaluate whether there is a difference in survival with xenon 50% and oxygen during targeted temperature management (TTM) compared with similar oxygen content in air during TTM in comatose subjects with sustained restoration of spontaneous circulation (ROSC) within 30 minutes after out-of-hospital cardiac arrest (OHCA).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age at least 18 years but less than or equal to 80 years
- •Presumed cardiac cause of arrest
- •Sustained (>20 minutes) spontaneous circulation upon arrival in the emergency department
- •No response to verbal commands on arrival to emergency department and prior to randomization (Glasgow Coma Scale score of <8)
- •Attending decision that patient is eligible for TTM
排除标准
- •Written do not attempt resuscitation reported to providers before randomization
- •Traumatic etiology of arrest, defined as concomitant blunt, penetrating, or burn-related injury, or uncontrolled bleeding or exsanguination
- •Suspected or known stroke or intracranial hemorrhage
- •Unwitnessed cardiac arrest
- •No-flow (cardiac arrest to initiation of cardiopulmonary resuscitation/defibrillation) time of >10 minutes
- •Sustained restoration of spontaneous circulation (ROSC) greater than 30- minutes post-arrest
- •Interval from arrival at the emergency department to randomization for intervention of >4 hours.
- •Hypothermia (<30°C core temperature)
- •Bed-bound prior to cardiac arrest
- •Unconsciousness before cardiac arrest (cerebral trauma, spontaneous cerebral hemorrhage, intoxication etc.)
- •Coagulopathy
- •Systolic arterial pressure <80 mmHg or mean arterial pressure <60 mmHg lasting more than 30 minutes after ROSC
- •Known pregnancy
- •Have received an investigational drug, device, or biologic product within 30-days
- •Known terminal phase of chronic illness
- •Hypoxemia (SaO2 <85%) for >15 minutes after ROSC
- •Inability to maintain SaO2 >90% on an FiO2 of 50%
- •Having any other clinically significant laboratory abnormality, medical condition (such as intrinsic liver disease or severe chronic obstructive pulmonary disease), or social circumstance that, in the investigator's opinion, makes it inappropriate for the patient to participate in this clinical trial
- •Logistically impossible to provide intervention
- •Have any condition that would impact the evaluation of modified Rankin Scale (mRS)
研究组 & 干预措施
TH/TTM
Protocol-directed standard of care (including TH/TTM) dictated by the 2015 guidelines for Post-Cardiac Arrest Care from the American Heart Association and the European Resuscitation Council. Mechanical Ventilation delivered by individual site-sanctioned ventilator.
TH/TTM plus Xenon
50% xenon gas in addition to standard of care, including therapeutic hypothermia/targeted temperature management (TH/TTM).
干预措施: Xenon (Combination Product)
结局指标
主要结局
functional outcome: degree of functional independence measured using a modified Rankin Scale (mRS)
时间窗: 30 days after the cardiac arrest
The degree of functional independence will be measured using a modified Rankin Scale (mRS)
次要结局
- survival: number of survivors(30 days after the cardiac arrest)