BACR group, Institute of Inflammation and Ageing, University of Birmingham, UK.
University of Michigan, Ann Arbor, MI, United States.
Resuscitation. 2018 Dec;133:101-107. doi: 10.1016/j.resuscitation.2018.09.011. Epub 2018 Oct 3.
Separate trials to evaluate therapeutic hypothermia after paediatric cardiac arrest for out-of-hospital and in-hospital settings reported no statistically significant differences in survival with favourable neurobehavioral outcome or safety compared to therapeutic normothermia. However, larger sample sizes might detect smaller clinical effects. Our aim was to pool data from identically conducted trials to approximately double the sample size of the individual trials yielding greater statistical power to compare outcomes.
Combine individual patient data from two clinical trials set in forty-one paediatric intensive care units in USA, Canada and UK. Children aged at least 48 h up to 18 years old, who remained comatose after resuscitation, were randomized within 6 h of return of circulation to hypothermia or normothermia (target 33.0 °C or 36.8 °C). The primary outcome, survival 12 months post-arrest with Vineland Adaptive Behaviour Scales, Second Edition (VABS-II) score at least 70 (scored from 20 to 160, higher scores reflecting better function, population mean = 100, SD = 15), was evaluated among patients with pre-arrest scores ≥70.
624 patients were randomized. Among 517 with pre-arrest VABS-II scores ≥70, the primary outcome did not significantly differ between hypothermia and normothermia groups (28% [75/271] and 26% [63/246], respectively; relative risk, 1.08; 95% confidence interval [CI], 0.81 to 1.42; p = 0.61). Among 602 evaluable patients, the change in VABS-II score from baseline to 12 months did not differ significantly between groups (p = 0.20), nor did, proportion of cases with declines no more than 15 points or improvement from baseline [22% (hypothermia) and 21% (normothermia)]. One-year survival did not differ significantly between hypothermia and normothermia groups (44% [138/317] and 38% [113/ 297], respectively; relative risk, 1.15; 95% CI, 0.95 to 1.38; p = 0.15). Incidences of blood-product use, infection, and serious cardiac arrhythmia adverse events, and 28-day mortality, did not differ between groups.
Analysis of combined data from two paediatric cardiac arrest targeted temperature management trials including both in-hospital and out-of-hospital cases revealed that hypothermia, as compared with normothermia, did not confer a significant benefit in survival with favourable functional outcome at one year.
分别评估儿科心脏骤停后治疗性低温的临床试验，无论是在院外还是院内设置，与治疗性正常体温相比，在存活并伴有良好神经行为结局或安全性方面均未显示出统计学显著差异。然而，更大的样本量可能会检测到更小的临床效果。我们的目的是汇集来自两个相同试验的个体患者数据，将每个试验的样本量增加一倍左右，从而获得更大的统计学效能来比较结局。
合并在美国、加拿大和英国的 41 个儿科重症监护病房进行的两项临床试验的个体患者数据。年龄至少 48 小时至 18 岁的患儿，在循环恢复后仍处于昏迷状态，在循环恢复后 6 小时内随机分为低温组或常温组（目标温度为 33.0°C 或 36.8°C）。主要结局是通过儿童适应行为量表第二版（VABS-II）评估 12 个月时的存活情况，该量表评分至少为 70 分（得分范围为 20 至 160 分，得分越高表示功能越好，人群平均值为 100，标准差为 15），在有预先存在的评分≥70 分的患者中进行评估。
共纳入 624 名患者。在 517 名预先存在的 VABS-II 评分≥70 分的患者中，低温组和常温组的主要结局无显著差异（分别为 28%[75/271]和 26%[63/246]；相对风险为 1.08；95%置信区间[CI]为 0.81 至 1.42；p=0.61）。在 602 名可评估的患者中，两组基线至 12 个月时的 VABS-II 评分变化无显著差异（p=0.20），基线时评分下降不超过 15 分或改善的比例也无显著差异[22%（低温组）和 21%（常温组）]。低温组和常温组 1 年生存率也无显著差异（分别为 44%[138/317]和 38%[113/297]；相对风险为 1.15；95%CI 为 0.95 至 1.38；p=0.15）。两组间血制品使用、感染和严重心律失常不良事件的发生率以及 28 天死亡率均无差异。
对两个儿科心脏骤停靶向体温管理试验的合并数据分析显示，与常温相比，低温并不能在 1 年时提高伴有良好功能结局的存活率。
