Targeted Temperature Management for Cardiac Arrest with Nonshockable Rhythm
Jean-Baptiste Lascarrou, Hamid Merdji, Amélie Le Gouge, et al
N Engl J Med October 2, 2019
DOI: 10.1056/NEJMoa1906661
BACKGROUND 背景
Moderate therapeutic hypothermia is currently recommended to improve neurologic outcomes in adults with persistent coma after resuscitated out-of-hospital cardiac arrest. However, the effectiveness of moderate therapeutic hypothermia in patients with nonshockable rhythms (asystole or pulseless electrical activity) is debated.
对于院外心跳骤停复苏后持续昏迷的成年患者，目前推荐采用中度治疗性低体温以改善神经系统预后。然而，中度治疗性低体温对于不可电击心率（心跳停搏或无脉电活动）的疗效尚存在争议。
METHODS 方法
We performed an open-label, randomized, controlled trial comparing moderate therapeutic hypothermia (33°C during the first 24 hours) with targeted normothermia (37°C) in patients with coma who had been admitted to the intensive care unit (ICU) after resuscitation from cardiac arrest with nonshockable rhythm. The primary outcome was survival with a favorable neurologic outcome, assessed on day 90 after randomization with the use of the Cerebral Performance Category (CPC) scale (which ranges from 1 to 5, with higher scores indicating greater disability). We defined a favorable neurologic outcome as a CPC score of 1 or 2. Outcome assessment was blinded. Mortality and safety were also assessed.
我们进行了一项开放标签、随机对照试验，对于不可电击心率造成的心跳骤停复苏后收入ICU的昏迷患者，将中度治疗性低体温 (最初24小时内33°C) 与正常体温 (37°C) 进行了比较。主要预后指标为存活且神经系统预后良好，于随机分组后90天根据脑功能分类(CPC)评分(分值1-5，分值越高提示功能障碍越明显)进行评估。我们将神经系统预后良好定义为CPC评分1分或2分。预后评估时设盲。同时对病死率及安全性进行评估。
RESULTS 结果
From January 2014 through January 2018, a total of 584 patients from 25 ICUs underwent randomization, and 581 were included in the analysis (3 patients withdrew consent). On day 90, a total of 29 of 284 patients (10.2%) in the hypothermia group were alive with a CPC score of 1 or 2, as compared with 17 of 297 (5.7%) in the normothermia group (difference, 4.5 percentage points; 95% confidence interval [CI], 0.1 to 8.9; P=0.04). Mortality at 90 days did not differ significantly between the hypothermia group and the normothermia group (81.3% and 83.2%, respectively; difference, −1.9 percentage points; 95% CI, −8.0 to 4.3). The incidence of prespecified adverse events did not differ significantly between groups.
从2014年1月至2018年1月，共有25个ICU的584名患者接受随机分组，其中581名患者纳入分析（3名患者撤除知情同意）。至第90天时，低体温组284名患者中29名(10.2%) 与正常体温组297名患者中17名 (5.7%) 仍然存活且CPC评分为1分或2分(差异, 4.5 个百分点; 95% 可信区间 [CI], 0.1 to 8.9; P=0.04)。低体温组与正常体温组90天病死率无显著差异(81.3% vs 83.2%; 差异, −1.9 个百分点; 95% CI, −8.0 to 4.3)。预先确定的不良事件两组间屋显著差异。
CONCLUSIONS 结论
Among patients with coma who had been resuscitated from cardiac arrest with nonshockable rhythm, moderate therapeutic hypothermia at 33°C for 24 hours led to a higher percentage of patients who survived with a favorable neurologic outcome at day 90 than was observed with targeted normothermia. (Funded by the French Ministry of Health and others; HYPERION ClinicalTrials.gov number, NCT01994772. opens in new tab.)
对于不可电击心率造成的心跳骤停复苏后昏迷患者，与维持正常体温目标相比，中度治疗性低体温33°C持续24小时可增加90天时存活且神经系统预后良好患者的比例。
