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[Lancet Respir Med在线发表]:CASS研究显示,诱导性低温治疗不能降低合并呼吸功能衰竭的感染性休克患者病死率
2018年02月06日 时讯速递, 进展交流 暂无评论

Induced hypothermia in patients with septic shock and respiratory failure (CASS): a randomised, controlled, open-label trial

Theis Skovsgaard Itenov, Maria Egede Johansen, Morten Bestle, et al.

Lancet Respir Med 2018 Published Online January 8, 2018

http://dx.doi.org/10.1016/S2213-2600(18)30004-3

Summary

Background 背景

Animal models of serious infection suggest that 24 h of induced hypothermia improves circulatory and respiratory function and reduces mortality. We tested the hypothesis that a reduction of core temperature to 32–34°C attenuates organ dysfunction and reduces mortality in ventilator-dependent patients with septic shock.

严重感染的动物模型显示,24小时诱导性低温能够改善循环和呼吸功能并降低病死率。我们验证如下假设,即对于呼吸机依赖的感染性休克患者,将核心体温降低到32–34°C,能够减轻器官功能障碍,降低病死率。

Methods 方法

In this randomised, controlled, open-label trial, we recruited patients from ten intensive care units (ICUs) in three countries in Europe and North America. Inclusion criteria for patients with severe sepsis or septic shock were a mean arterial pressure of less than 70 mm Hg, mechanical ventilation in an ICU, age at least 50 years, predicted length of stay in the ICU at least 24 h, and recruitment into the study within 6 h of fulfilling inclusion criteria. Exclusion criteria were uncontrolled bleeding, clinically important bleeding disorder, recent open surgery, pregnancy or breastfeeding, or involuntary psychiatric admission. We randomly allocated patients 1:1 (with variable block sizes ranging from four to eight; stratified by predictors of mortality, age, Acute Physiology and Chronic Health Evaluation II score, and study site) to routine thermal management or 24 h of induced hypothermia (target 32–34°C) followed by 48 h of normothermia (36–38°C). The primary endpoint was 30 day all-cause mortality in the modified intention-to-treat population (all randomly allocated patients except those for whom consent was withdrawn or who were discovered to meet an exclusion criterion after randomisation but before receiving the trial intervention). Patients and health-care professionals giving the intervention were not masked to treatment allocation, but assessors of the primary outcome were. This trial is registered with ClinicalTrials.gov, number NCT01455116.

在这项随机对照开放研究中,我们入选了欧洲及北美3个国家10个ICU的患者。严重全身性感染及感染性休克患者的入选标准为平均动脉压不足70 mmHg,在ICU接受机械通气,年龄至少50岁,预计ICU住院时间至少24小时,且在满足入选标准6小时内纳入研究。排除标准包括未能控制的出血,临床重要的出血性疾病,近期开放手术,妊娠或哺乳,或因精神疾病入院。我们将入选患者按照1:1的比例随机分组(群组大小为4-8不等;根据病死率预测指标,年龄,APACHE II评分及参研中心进行分层),包括常规治疗组或24小时诱导性低温组(目标温度32–34°C,随后维持正常体温[36–38°C] 48小时)。主要预后终点为修订后意向治疗人群(接受随机分组的所有患者,除外撤除知情同意或随机分组后接受试验治疗前发现符合排除标准的患者)的30天全因病死率。分组情况对患者及负责治疗的医务人员并不隐藏,但主要预后终点的评估者不了解治疗分组情况。试验在 ClinicalTrials.gov注册,注册号NCT01455116.

Findings 结果

Between Nov 1, 2011, and Nov 4, 2016, we screened 5695 patients. After recruitment of 436 of the planned 560 participants, the trial was terminated for futility (220 [50%] randomly allocated to hypothermia and 216 [50%] to routine thermal management). In the hypothermia group, 96 (44·2%) of 217 died within 30 days versus 77 (35·8%) of 215 in the routine thermal management group (difference 8·4% [95% CI –0·8 to 17·6]; relative risk 1·2 [1·0–1·6]; p=0·07]).

2011年11月1日至2016年11月4日之间,我们共筛查了5696名患者。研究计划入选560名患者,纳入436名患者后,因治疗无效(220名 [50%] 患者随机分至低温治疗组,216名 [50%] 患者分至常规体温治疗组)终止试验。30天时,低温治疗组的217名患者中96名 (44·2%) 死亡,常规治疗组215名患者中 77名 (35·8%) 死亡(差异8·4% [95% CI –0·8 to 17·6]; 相对危险度 1·2 [1·0–1·6]; p=0·07])。

Interpretation 结论

Among patients with septic shock and ventilator-dependent respiratory failure, induced hypothermia does not reduce mortality. Induced hypothermia should not be used in patients with septic shock.

对于合并呼吸机依赖的呼吸功能衰竭的感染性休克患者,诱导性低温治疗不能降低病死率。诱导性低温不应用于感染性休克患者。

Funding 资助

Trygfonden, Lundbeckfonden, and the Danish National Research Foundation.

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