心脏骤停与复苏后针对低正常或高正常二氧化碳、氧气和平均动脉压的研究：一项随机试点试验的研究方案
Targeting low- or high-normal Carbon dioxide, Oxygen, and Mean arterial pressure After Cardiac Arrest and REsuscitation: study protocol for a randomized pilot trial.
作者信息
Jakkula Pekka, Reinikainen Matti, Hästbacka Johanna, Pettilä Ville, Loisa Pekka, Karlsson Sari, Laru-Sompa Raili, Bendel Stepani, Oksanen Tuomas, Birkelund Thomas, Tiainen Marjaana, Toppila Jussi, Hakkarainen Antti, Skrifvars Markus B
机构信息
University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
North Karelia Central Hospital, Joensuu, Finland.
出版信息
Trials. 2017 Oct 30;18(1):507. doi: 10.1186/s13063-017-2257-0.
BACKGROUND
Arterial carbon dioxide tension (PaCO), oxygen tension (PaO), and mean arterial pressure (MAP) are modifiable factors that affect cerebral blood flow (CBF), cerebral oxygen delivery, and potentially the course of brain injury after cardiac arrest. No evidence regarding optimal treatment targets exists.
METHODS
The Carbon dioxide, Oxygen, and Mean arterial pressure After Cardiac Arrest and REsuscitation (COMACARE) trial is a pilot multi-center randomized controlled trial (RCT) assessing the feasibility of targeting low- or high-normal PaCO, PaO, and MAP in comatose, mechanically ventilated patients after out-of-hospital cardiac arrest (OHCA), as well as its effect on brain injury markers. Using a 2 factorial design, participants are randomized upon admission to an intensive care unit into one of eight groups with various combinations of PaCO, PaO, and MAP target levels for 36 h after admission. The primary outcome is neuron-specific enolase (NSE) serum concentration at 48 h after cardiac arrest. The main feasibility outcome is the between-group differences in PaCO2, PaO2, and MAP during the 36 h after ICU admission. Secondary outcomes include serum concentrations of NSE, S100 protein, and cardiac troponin at 24, 48, and 72 h after cardiac arrest; cerebral oxygenation, measured with near-infrared spectroscopy (NIRS); potential differences in epileptic activity, monitored via continuous electroencephalogram (EEG); and neurological outcomes at six months after cardiac arrest.
DISCUSSION
The trial began in March 2016 and participant recruitment has begun in all seven study sites as of March 2017. Currently, 115 of the total of 120 patients have been included. When completed, the results of this trial will provide preliminary clinical evidence regarding the feasibility of targeting low- or high-normal PaCO, PaO, and MAP values and its effect on developing brain injury, brain oxygenation, and epileptic seizures after cardiac arrest. The results of this trial will be used to evaluate whether a larger RCT on this subject is justified.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT02698917 . Registered on 26 January 2016.
背景
动脉血二氧化碳分压（PaCO₂）、氧分压（PaO₂）和平均动脉压（MAP）是可调节的因素，会影响脑血流量（CBF）、脑氧输送，并可能影响心脏骤停后脑损伤的进程。目前尚无关于最佳治疗目标的证据。
方法
心脏骤停与复苏后的二氧化碳、氧气和平均动脉压（COMACARE）试验是一项多中心随机对照试验（RCT），旨在评估对院外心脏骤停（OHCA）后昏迷、接受机械通气的患者设定低或高正常范围的PaCO₂、PaO₂和MAP目标的可行性，以及其对脑损伤标志物的影响。采用2×2析因设计，参与者在入住重症监护病房时被随机分为八组中的一组，在入院后36小时内接受不同组合的PaCO₂、PaO₂和MAP目标水平。主要结局是心脏骤停后48小时神经元特异性烯醇化酶（NSE）血清浓度。主要可行性结局是入住重症监护病房后36小时内各治疗组之间PaCO₂、PaO₂和MAP的差异。次要结局包括心脏骤停后24、48和72小时NSE、S100蛋白和心肌肌钙蛋白的血清浓度；用近红外光谱（NIRS）测量的脑氧合；通过连续脑电图（EEG）监测的癫痫活动的潜在差异；以及心脏骤停后6个月的神经学结局。
讨论
该试验于2016年3月开始，截至2017年3月，所有七个研究地点均已开始招募参与者。目前，120名患者中的115名已被纳入研究。试验完成后，其结果将为设定低或高正常范围的PaCO₂、PaO₂和MAP值的可行性及其对心脏骤停后脑损伤、脑氧合和癫痫发作的影响提供初步临床证据。该试验结果将用于评估是否有必要针对该主题开展更大规模的随机对照试验。
试验注册
ClinicalTrials.gov，NCT02698917。于2016年1月26日注册。
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