The aim of this study was to assess whether hypothermia increased survival and improved functional outcome when compared with normothermia in out-of-hospital cardiac arrest (OHCA) patients with similar characteristics than in previous randomized studies showing benefits for hypothermia. Post hoc analysis of a pragmatic, multicenter, randomized clinical trial (TTM-2, NCT02908308). In this analysis, the subset of patients included in the trial who had similar characteristics to patients included in one previous randomized trial and randomized to hypothermia at 33 °C or normothermia (i.e. target < 37.8 °C) were considered. The primary outcome was survival at 6 months; secondary outcomes included favorable functional outcome at 6 months, defined as a modified Rankin scale of 0–3. Time-to-death and the occurrence of adverse events were also reported. From a total of 1891 included in the TTM-2 study, 600 (31.7%) were included in the analysis, 294 in the hypothermia and 306 in the normothermia group. At 6 months, 207 of the 294 patients (70.4%) in the hypothermia group and 220 of the 306 patients (71.8%) in the normothermia group had survived (relative risk with hypothermia, 0.96; 95% confidence interval [CI], 0.81 to 1.15; P = 0.71). Also, 198 of the 294 (67.3%) in the hypothermia group and 202 of the 306 (66.0%) in the normothermia group had a favorable functional outcome (relative risk with hypothermia, 1.03; 95% CI, 0.87 to 1.23; P = 0.79). There was a significant increase in the occurrence of arrythmias in the hypothermia group (62/294, 21.2%) when compared to the normothermia group (43/306, 14.1%—OR 1.49, 95% CI 1.05–2.14; p = 0.026). In this study, hypothermia at 33˚C did not improve survival or functional outcome in a subset of patients with similar cardiac arrest characteristics to patients in whom benefit from hypothermia was shown in prior studies.

中文翻译：

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心脏骤停和可电击心律患者的体温过低与体温正常：TTM-2 研究的二次分析


本研究的目的是评估与正常体温相比，低体温是否能提高院外心脏骤停 （OHCA） 患者的生存率并改善功能结果，这些患者的特征与以前的随机研究相似，显示出对低体温的益处。实用、多中心、随机临床试验 （TTM-2， NCT02908308） 的事后分析。在该分析中，考虑了试验中纳入的患者子集，这些患者与之前一项随机试验中纳入的患者具有相似的特征，并被随机分配到 33 °C 或正常体温 （即 目标 < 37.8 °C） 被考虑。主要结局是 6 个月生存率;次要结果包括 6 个月时良好的功能结果，定义为改良的 Rankin 量表为 0-3。还报告了死亡时间和不良事件的发生率。在 TTM-2 研究共纳入的 1891 例中，600 例 （31.7%） 被纳入分析，体温过低组 294 例，常温组 306 例。6 个月时，低温组 294 例患者中有 207 例 （70.4%） 存活，常温组 306 例患者中有 220 例 （71.8%） 存活（低温相对风险，0.96;95% 置信区间 [CI]，0.81 至 1.15;P = 0.71）。此外，体温过低组 294 例中的 198 例 （67.3%） 和常温组 306 例中的 202 例 （66.0%） 具有良好的功能结局（体温过低的相对风险，1.03;95% CI，0.87 至 1.23;P = 0.79）。与正常体温组 （43/306， 14.1%—OR 1.49， 95% CI 1.05–2.14;p = 0.026） 相比，体温过低组 （62/294， 21.2%） 的心律失常发生率显著增加。 在这项研究中，33°C 的低温并未改善与先前研究中显示从低温中受益的患者具有相似心脏骤停特征的患者子集的生存率或功能结果。