Therapeutic Hypothermia after In-Hospital Cardiac Arrest in Children.
Therapeutic Hypothermia after In-Hospital Cardiac Arrest in Children.
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DOI：
10.1056/nejmoa1610493
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发表时间：
2017-01-26
期刊：
影响因子：
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通讯作者：
THAPCA Trial Investigators
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作者：
Moler FW;Silverstein FS;Holubkov R;Slomine BS;Christensen JR;Nadkarni VM;Meert KL;Browning B;Pemberton VL;Page K;Gildea MR;Scholefield BR;Shankaran S;Hutchison JS;Berger JT;Ofori-Amanfo G;Newth CJ;Topjian A;Bennett KS;Koch JD;Pham N;Chanani NK;Pineda JA;Harrison R;Dalton HJ;Alten J;Schleien CL;Goodman DM;Zimmerman JJ;Bhalala US;Schwarz AJ;Porter MB;Shah S;Fink EL;McQuillen P;Wu T;Skellett S;Thomas NJ;Nowak JE;Baines PB;Pappachan J;Mathur M;Lloyd E;van der Jagt EW;Dobyns EL;Meyer MT;Sanders RC Jr;Clark AE;Dean JM;THAPCA Trial Investigators
院外心脏骤停后，建议对昏迷的成人和儿童进行有针对性的体温管理；然而，关于院内心脏骤停后体温管理的数据有限。在37家儿童医院进行的一项试验中，我们比较了两种温度干预对院内心脏骤停儿童的影响。在血液循环恢复后6小时内，将年龄大于48小时且年龄小于18岁的昏迷儿童随机分配到治疗性低温治疗组（目标温度为33.0℃）或治疗性常温治疗组（目标温度为36.8℃）。主要疗效指标是在心脏骤停前VABS-II评分至少为70分或更高的Vineland适应行为量表第二版（VABS-II，评分范围从20到160，分数越高表明功能越好）患者中评估心脏骤停后12个月的生存率。在329名患者接受随机分组后，试验因无效而终止。在257例心脏骤停前VABS-II评分至少为70分且可进行评估的患者中，低温组和常温组的主要疗效转归率无显著差异（分别为36%[133例患者中48例]和39%[124例患者中48例]；相对风险为0.92；95%可信区间[CI]， 0.67 ~ 1.27; P = 0.63）。在317例可以评估神经行为功能变化的患者中，VABS-II评分从基线到12个月的变化在两组之间没有显著差异（P = 0.70）。在327例可评估1年生存率的患者中，低温组和常温组的1年生存率无显著差异（分别为49%[166例中81例]和46%[161例中74例]；相对危险度为1.07；95% CI为0.85 ~ 1.34;P = 0.56）。血液制品使用、感染和严重不良事件的发生率以及28天死亡率在两组之间没有显著差异。在医院内心脏骤停存活的昏迷儿童中，治疗性低温与治疗性常温相比，在1年生存率和良好的功能结局方面没有显著的益处。（由国家心脏、肺和血液研究所资助；THAPCA-IH ClinicalTrials.gov号码：NCT00880087。）
Targeted temperature management is recommended for comatose adults and children after out-of-hospital cardiac arrest; however, data on temperature management after in-hospital cardiac arrest are limited. In a trial conducted at 37 children’s hospitals, we compared two temperature interventions in children who had had in-hospital cardiac arrest. Within 6 hours after the return of circulation, comatose children older than 48 hours and younger than 18 years of age were randomly assigned to therapeutic hypothermia (target temperature, 33.0°C) or therapeutic normothermia (target temperature, 36.8°C). The primary efficacy outcome, survival at 12 months after cardiac arrest with a score of 70 or higher on the Vineland Adaptive Behavior Scales, second edition (VABS-II, on which scores range from 20 to 160, with higher scores indicating better function), was evaluated among patients who had had a VABS-II score of at least 70 before the cardiac arrest. The trial was terminated because of futility after 329 patients had undergone randomization. Among the 257 patients who had a VABS-II score of at least 70 before cardiac arrest and who could be evaluated, the rate of the primary efficacy outcome did not differ significantly between the hypothermia group and the normothermia group (36% [48 of 133 patients] and 39% [48 of 124 patients], respectively; relative risk, 0.92; 95% confidence interval [CI], 0.67 to 1.27; P = 0.63). Among 317 patients who could be evaluated for change in neurobehavioral function, the change in VABS-II score from baseline to 12 months did not differ significantly between the groups (P = 0.70). Among 327 patients who could be evaluated for 1-year survival, the rate of 1-year survival did not differ significantly between the hypothermia group and the normothermia group (49% [81 of 166 patients] and 46% [74 of 161 patients], respectively; relative risk, 1.07; 95% CI, 0.85 to 1.34; P = 0.56). The incidences of blood-product use, infection, and serious adverse events, as well as 28-day mortality, did not differ significantly between groups. Among comatose children who survived in-hospital cardiac arrest, therapeutic hypothermia, as compared with therapeutic normothermia, did not confer a significant benefit in survival with a favorable functional outcome at 1 year. (Funded by the National Heart, Lung, and Blood Institute; THAPCA-IH ClinicalTrials.gov number, NCT00880087.)