Carbon Dioxide, Oxygen and Mean Arterial Pressure After Cardiac Arrest and Resuscitation - Targeting High vs. Low Normal Values
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 7
- 主要终点
- Neuron-specific enolase (NSE) serum concentration
研究概览
简要总结
The COMACARE trial is a pilot multicenter randomized trial to assess the feasibility and effect on brain injury markers of targeting low or high normal arterial oxygen tension (PaO2), arterial carbon dioxide tension (PaCO2) and mean arterial pressure (MAP) in comatose, mechanically ventilated patients after out-of-hospital cardiac arrest. Using factorial design, participants are randomized at admission to intensive care unit to one of eight groups targeting either low or high normal values of PaO2, PaCO2 and MAP for 36 h. In this way, investigators will be assessing the feasibility and effect of all three variables at the same time.
The primary outcome is serum concentration of neuron-specific enolase (NSE) at 48 h after cardiac arrest. Feasibility outcome is between-group separation in PaO2, PaCO2 and MAP levels. Secondary outcomes include continuous monitoring of cerebral oxygenation, EEG and ECG for 48 h, the levels of NSE, S100B and cardiac troponin at randomization and 24, 48 and 72 h after cardiac arrest and neurological assessment at 6 months after cardiac arrest.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The physician determining neurological outcome at six months after cardiac arrest is blinded to the study group allocations
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
- •Witnessed out-of-hospital cardiac arrest with ventricular fibrillation (VF) or ventricular tachycardia (VT) as the initial rhythm
- •Delay of return of spontaneous circulation (ROSC) 10-45 min from the start of the arrest
- •Confirmed or suspected cardiac origin
- •Mechanical ventilation
- •Markedly impaired level of consciousness (no response to verbal commands and Glasgow coma scale [GCS] motor score < 5)
- •Deferred consent possible or likely
- •Active intensive care initiated, including targeted temperature management (33-36 C)
排除标准
- •Probable withdrawal of active ICU care due to terminal illness or poor prognosis because of severely reduced functional status before cardiac arrest
- •Confirmed or suspected intracranial pathology and/or suspicion of raised intracranial pressure
- •Pregnancy
- •Severe oxygenation problem (PaO2 / FiO2 < 100 mmHg)
- •Severe COPD
结局指标
主要结局
Neuron-specific enolase (NSE) serum concentration
时间窗: 48 hour after cardiac arrest
次要结局
- Cardiac troponin (TnT) serum concentration(At randomization and 24, 48 and 72 hour after cardiac arrest)
- Continuous electroencephalography (EEG) monitoring(For 48 hour after admission to ICU)
- S100B protein serum concentration(At randomization and 24, 48 and 72 hour after cardiac arrest)
- Cerebral oxygenation monitoring using near infrared spectroscopy (NIRS) monitoring(For 48 hour after admission to ICU)
- Neuron-specific enolase (NSE) serum concentration(At randomization and 24 and 72 hour after cardiac arrest)
- Functional status using cerebral performance category (CPC) classification(At 30 days and 6 months after cardiac arrest)
研究者
Pekka Jakkula
MD
Helsinki University Central Hospital