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法国重症老年患者系统性重症监护病房分诊对长期死亡率的影响:一项随机临床试验

Effect of Systematic Intensive Care Unit Triage on Long-term Mortality Among Critically Ill Elderly Patients in France: A Randomized Clinical Trial.

作者信息

Guidet Bertrand, Leblanc Guillaume, Simon Tabassome, Woimant Maguy, Quenot Jean-Pierre, Ganansia Olivier, Maignan Maxime, Yordanov Youri, Delerme Samuel, Doumenc Benoit, Fartoukh Muriel, Charestan Pierre, Trognon Pauline, Galichon Bertrand, Javaud Nicolas, Patzak Anabela, Garrouste-Orgeas Maïté, Thomas Caroline, Azerad Sylvie, Pateron Dominique, Boumendil Ariane

机构信息

Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Saint-Antoine, Service de Réanimation Médicale, Paris, France.

Sorbonne Universités, Université Pierre et Marie Curie, Paris, France.

出版信息

JAMA. 2017 Oct 17;318(15):1450-1459. doi: 10.1001/jama.2017.13889.

Abstract

IMPORTANCE

The high mortality rate in critically ill elderly patients has led to questioning of the beneficial effect of intensive care unit (ICU) admission and to a variable ICU use among this population.

OBJECTIVE

To determine whether a recommendation for systematic ICU admission in critically ill elderly patients reduces 6-month mortality compared with usual practice.

DESIGN, SETTING, AND PARTICIPANTS: Multicenter, cluster-randomized clinical trial of 3037 critically ill patients aged 75 years or older, free of cancer, with preserved functional status (Index of Independence in Activities of Daily Living ≥4) and nutritional status (absence of cachexia) who arrived at the emergency department of one of 24 hospitals in France between January 2012 and April 2015 and were followed up until November 2015.

INTERVENTIONS

Centers were randomly assigned either to use a program to promote systematic ICU admission of patients (n=1519 participants) or to follow standard practice (n=1518 participants).

MAIN OUTCOMES AND MEASURES

The primary outcome was death at 6 months. Secondary outcomes included ICU admission rate, in-hospital death, functional status, and quality of life (12-Item Short Form Health Survey, ranging from 0 to 100, with higher score representing better self-reported health) at 6 months.

RESULTS

One patient withdrew consent, leaving 3036 patients included in the trial (median age, 85 [interquartile range, 81-89] years; 1361 [45%] men). Patients in the systematic strategy group had an increased risk of death at 6 months (45% vs 39%; relative risk [RR], 1.16; 95% CI, 1.07-1.26) despite an increased ICU admission rate (61% vs 34%; RR, 1.80; 95% CI, 1.66-1.95). After adjustments for baseline characteristics, patients in the systematic strategy group were more likely to be admitted to an ICU (RR, 1.68; 95% CI, 1.54-1.82) and had a higher risk of in-hospital death (RR, 1.18; 95% CI, 1.03-1.33) but had no significant increase in risk of death at 6 months (RR, 1.05; 95% CI, 0.96-1.14). Functional status and physical quality of life at 6 months were not significantly different between groups.

CONCLUSIONS AND RELEVANCE

Among critically ill elderly patients in France, a program to promote systematic ICU admission increased ICU use but did not reduce 6-month mortality. Additional research is needed to understand the decision to admit elderly patients to the ICU.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT01508819.

摘要

重要性

重症老年患者的高死亡率引发了对重症监护病房(ICU)收治有益效果的质疑,且该人群中ICU的使用情况存在差异。

目的

确定与常规治疗相比,对重症老年患者进行系统性ICU收治的建议是否能降低6个月死亡率。

设计、设置和参与者:对3037例75岁及以上、无癌症、功能状态良好(日常生活活动独立指数≥4)且营养状况良好(无恶病质)的重症患者进行多中心、整群随机临床试验。这些患者于2012年1月至2015年4月期间抵达法国24家医院之一的急诊科,并随访至2015年11月。

干预措施

各中心被随机分配,要么采用促进患者系统性入住ICU的方案(n = 1519名参与者),要么遵循标准治疗(n = 1518名参与者)。

主要结局和测量指标

主要结局是6个月时的死亡。次要结局包括ICU收治率、住院死亡、功能状态以及6个月时的生活质量(12项简短健康调查问卷,范围为0至100,分数越高表示自我报告的健康状况越好)。

结果

1例患者撤回同意书,试验纳入3036例患者(中位年龄85岁[四分位间距,81 - 89岁];1361例[45%]为男性)。尽管系统性策略组的ICU收治率有所增加(61%对34%;相对风险[RR],1.80;95%置信区间,1.66 - 1.95),但该组患者在6个月时死亡风险增加(45%对39%;RR,1.16;95%置信区间,1.07 - 1.26)。在对基线特征进行调整后,系统性策略组的患者更有可能入住ICU(RR,1.68;95%置信区间,1.54 - 1.82),且住院死亡风险更高(RR,1.18;95%置信区间,1.03 - 1.33),但6个月时死亡风险无显著增加(RR,1.05;95%置信区间,0.96 - 1.14)。两组在6个月时的功能状态和身体生活质量无显著差异。

结论和相关性

在法国的重症老年患者中,促进系统性ICU收治的方案增加了ICU的使用,但未降低6个月死亡率。需要进一步研究以了解老年患者入住ICU的决策。

试验注册号

clinicaltrials.gov标识符:NCT01508819。

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