From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.
N Engl J Med. 2019 Dec 12;381(24):2327-2337. doi: 10.1056/NEJMoa1906661. Epub 2019 Oct 2.
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.
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.
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.
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.).
目前推荐中度治疗性低温以改善复苏后持续性昏迷的院外心脏骤停成人的神经功能结局。然而，对于无除颤节律（心搏停止或无脉电活动）的患者，中度治疗性低温的有效性存在争议。
我们进行了一项开放性标签、随机对照试验，比较了中度治疗性低温（复苏后 24 小时内 33°C）与目标性正常体温（37°C）在无除颤节律心脏骤停后入住 ICU 的昏迷患者中的作用。主要结局是使用神经功能预后量表（Cerebral Performance Category，CPC）评估的随机分组后第 90 天的存活且具有良好神经功能结局，CPC 量表的范围为 1 至 5 分，分数越高表示残疾程度越高。我们将良好的神经功能结局定义为 CPC 评分为 1 或 2。结局评估采用盲法。还评估了死亡率和安全性。
2014 年 1 月至 2018 年 1 月，来自 25 个 ICU 的 584 名患者进行了随机分组，581 名患者纳入分析（3 名患者撤回同意）。在第 90 天，低温组 284 名患者中有 29 名（10.2%）存活且 CPC 评分为 1 或 2，而常温组 297 名患者中有 17 名（5.7%）存活且 CPC 评分为 1 或 2（差异为 4.5 个百分点；95%置信区间为 0.1 至 8.9；P=0.04）。90 天死亡率在低温组和常温组之间无显著差异（分别为 81.3%和 83.2%；差异为-1.9 个百分点；95%置信区间为-8.0 至 4.3）。两组不良事件的发生率无显著差异。
对于无除颤节律心脏骤停后复苏的昏迷患者，24 小时 33°C 的中度治疗性低温导致第 90 天存活且具有良好神经功能结局的患者比例高于目标性正常体温。（由法国卫生部等资助；HYPERION 临床试验.gov 编号，NCT01994772）。
