Cerebral Oximetry in Management of Post Cardiac Arrest (COMPACT): A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Area under the curve (RSO2 < 60%)
研究概览
简要总结
Resuscitation from a cardiac arrest is a common reason for admission to an intensive care unit (ICU).
Because the brain is highly vulnerable to oxygen deprivation, severe brain damage often occurs during a cardiac arrest. Even when the heart has been restarted, there may continue to be reduced blood flow and oxygen delivery to the brain for many hours. ICU professionals generally do not use any tools to detect low oxygen delivery to the brain.
Most patients admitted to the ICU are initially in a coma and many will never awaken. Even if they regain consciousness, there may be long-term cognitive and functional disabilities. There are currently no specific treatments available to ICU professionals that are proven to limit brain damage and improve outcomes.
Cerebral oximetry is a non-invasive, painless, safe, and easy-to-use tool that detects reduced oxygen delivery to the brain using a sensor over the forehead. Previous research shows that reduced brain oxygen levels [(regional oxygen saturation (RSO2)] are predictive of a lower chance of awakening and having a good neurological recovery.
This study will assess treatment guided by cerebral oximetry during the initial 48 hours following cardiac arrest. Patients that are in a coma after their circulation has been restarted will be randomly allocated to either usual care based on international guidelines or a protocol aimed at maintaining RSO2 above 60% on both sides of the brain.
Cerebral oximetry will be recorded in all patients, but doctors will only be aware of it in one group. If RSO2 drops below 60% for more than 5 minutes, doctors will try to increase it. Actions taken to increase RSO2 may include raising the blood pressure by giving more intravenous fluid or using life-support drugs ("vasoconstrictors" like norepinephrine), stimulating the heart to pump more strongly with medications ("inotropes" like dobutamine, milrinone, or epinephrine), adjusting ventilator settings (to increase the amount of oxygen dissolved in blood or raise carbon dioxide levels, which increases blood flow to the brain), lowering the head of the bed (to increase blood flow to the brain), or giving a blood transfusion (only if the patient has anemia). When RSO2 has been corrected to at least 60% for more than 2 hours, doctors may reverse previous interventions. If they are unable to achieve the goal of 60%, they may lower the target. Efforts to maintain RSO2 in the target range will continue for 48 hours.
Investigators will assess how well the protocol works and whether it helps avoid critically low brain oxygen levels. Investigators will also measure various "biomarkers" in the blood that are released when the brain is damaged to see if they are lower when cerebral oximetry is used to guide treatment.
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
盲法说明
There is no masking of which group the patient is in. However, for patients in the control arm, ICU professionals are masked to the cerebral oximetry readings.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 18 years
- •Cardiac arrest (in- or out-of-hospital) lasting >= 5 minutes
- •Glasgow Coma Scale score <= 8 and motor score <= 5
排除标准
- •Cardiac arrest cause was any form of brain injury
- •Cannot be enrolled within 6 hours
- •Unsupportable physiology
- •CT scan (not mandated) showing diffuse loss of grey-white differentiation
研究组 & 干预措施
Cerebral oximetry-guided treatment
Clinicians are unmasked to regional oxygen saturation levels and attempt to maintain it at 60% or above.
干预措施: Cerebral oximetry-guided treatment (Other)
Standard care
Clinicians are unaware of regional oxygen saturation levels and manage patients in accordance with international (ILCOR) guidelines.
结局指标
主要结局
Area under the curve (RSO2 < 60%)
时间窗: 48 hours (2880 minutes)
Sum of right and left forehead area under the curve (AUC), where AUC = (average reduction in RSO2 below 60% per minute) x (2880 minutes)
次要结局
- Area under the curve (RSO2 < 60%) in patients where initial RSO2 < 60%(48 hours (2880 minutes))
- Proportion of monitoring time with RSO2 < 60%(Maximum of 48 hours (2880 minutes))
- Proportion of monitoring time with RSO2 < 60% in patients where initial RSO2 < 60%(Maximum of 48 hours (2880 minutes))
- Change in RSO2 over time in patients where baseline level < 60%(Initial 6 hours)
- Dichotomized Cerebral Performance Category (CPC)(3 months)
- 28-day mortality(28 days)
- Difference between baseline and day 3 biomarker levels(3 days)
- Optic nerve sheath diameter(Days 1, 2, and 3 post-arrest)
- Serious Adverse Events (SAE)(Initial 7 days post-arrest)