Hypothermia in Comatose Survivors From Out-of-Hospital Cardiac Arrest Pilot Trial Comparing 2 Levels of Target Temperature
Hypothermia in Comatose Survivors From Out-of-Hospital Cardiac Arrest Pilot Trial Comparing 2 Levels of Target Temperature
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DOI：
10.1161/circulationaha.112.136408
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发表时间：
2012-12-11
期刊：
影响因子：
37.8
通讯作者：
Lopez-Sendon, Jose
中科院分区：
文献类型：
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作者：
Lopez-de-Sa, Esteban;Rey, Juan R.;Lopez-Sendon, Jose
背景-建议将院外心脏骤停的昏迷幸存者冷却至32度至34度，持续12至24小时。然而，最佳冷却水平是未知的。这项初步研究的目的是获得有关不同水平低温影响的初步数据。我们假设，更深的温度将与更好的生存和神经outcome.Methods和结果，患者有资格，如果他们有一个见证了院外心脏骤停从2008年3月至2011年8月。目标温度随机分配为32 ℃或34 ℃。根据初始心律（可电击或心搏停止）对入组进行分层。在24小时内维持目标温度，然后进行12至24小时的受控复温。主要结局是6个月时无严重依赖（Barthel指数评分>= 60分）的生存率。36例患者入组试验（26例可电击心律，10例心搏停止），其中18例被分配到34 ℃和18至32 ℃。32 ℃组18例患者中有8例（44.4%）达到主要终点，而34 ℃组18例患者中有2例（11.1%）达到主要终点（对数秩P = 0.12）。两组患者均在6个月内死亡，初始心律为心搏停止。初始可电击心律分配至32 ℃的13例患者中有8例（61.5%）在6个月时无严重依赖性存活，而分配至34 ℃的13例患者中有2例（15.4%）存活（对数秩P = 0.029）。两组的并发症发生率相似，但临床癫痫发作的发生率除外，32 ℃组患者的临床癫痫发作发生率低于34 ℃组患者（1 vs 11; P = 0.0002）。相反，在32 ℃的患者中有心动过缓发生率较高的趋势（7 vs 2; P = 0.054）。虽然钾水平下降到更大程度的患者分配到32摄氏度，低钾血症的发生率是相似的，在这两个groups. Conclusions-该试验的结果表明，较低的冷却水平可能与更好的结果在医院外的心脏骤停继发于一个可电击的节奏的患者生存。本文观察到的益处值得在具有不同呈现节律的院外心脏骤停患者中进行更大规模的试验中进一步研究。临床试验注册-URL：http://www.clinicaltrials.gov。唯一标识符：NCT 01155622。（循环。2012; 126：2826-2833）。
Background-It is recommended that comatose survivors of out-of-hospital cardiac arrest should be cooled to 32 degrees to 34 degrees C for 12 to 24 hours. However, the optimal level of cooling is unknown. The aim of this pilot study was to obtain initial data on the effect of different levels of hypothermia. We hypothesized that deeper temperatures will be associated with better survival and neurological outcome.Methods and Results-Patients were eligible if they had a witnessed out-of-hospital cardiac arrest from March 2008 to August 2011. Target temperature was randomly assigned to 32 degrees C or 34 degrees C. Enrollment was stratified on the basis of the initial rhythm as shockable or asystole. The target temperature was maintained during 24 hours followed by 12 to 24 hours of controlled rewarming. The primary outcome was survival free from severe dependence (Barthel Index score >= 60 points) at 6 months. Thirty-six patients were enrolled in the trial (26 shockable rhythm, 10 asystole), with 18 assigned to 34 degrees C and 18 to 32 degrees C. Eight of 18 patients in the 32 degrees C group (44.4%) met the primary end point compared with 2 of 18 in the 34 degrees C group (11.1%) (log-rank P = 0.12). All patients whose initial rhythm was asystole died before 6 months in both groups. Eight of 13 patients with initial shockable rhythm assigned to 32 degrees C (61.5%) were alive free from severe dependence at 6 months compared with 2 of 13 (15.4%) assigned to 34 degrees C (log-rank P = 0.029). The incidence of complications was similar in both groups except for the incidence of clinical seizures, which was lower (1 versus 11; P = 0.0002) in patients assigned to 32 degrees C compared with 34 degrees C. On the contrary, there was a trend toward a higher incidence of bradycardia (7 versus 2; P = 0.054) in patients assigned to 32 degrees C. Although potassium levels decreased to a greater extent in patients assigned to 32 degrees C, the incidence of hypokalemia was similar in both groups.Conclusions-The findings of this pilot trial suggest that a lower cooling level may be associated with a better outcome in patients surviving out-of-hospital cardiac arrest secondary to a shockable rhythm. The benefits observed here merit further investigation in a larger trial in out-of-hospital cardiac arrest patients with different presenting rhythms.Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01155622. (Circulation. 2012; 126: 2826-2833.)