法国巴黎大学Alexandre Mebazaa联合索邦大学Yonathan Freund团队研究了急诊室综合护理对老年急性心力衰竭患者30天出院生存的影响。2020年11月17日，该研究发表在《美国医学会杂志》上。

急诊室（ED）急性心力衰竭早期处理的临床指南仅基于中等水平的证据，人们对这些指南的依从性较低。

为了评估早期指南推荐的护理组合对ED老年急性心力衰竭患者近期预后的影响，2018年12月至2019年9月，研究组在法国15个急诊室对503名75岁及以上诊断为急性心力衰竭的患者进行了一项阶梯式楔形聚类随机试验，均随访30日。将患者随机分组，其中200例接受干预治疗，包括早期静脉注射硝酸盐、治疗急性冠状动脉综合征、感染或心房颤动等诱发因素、静脉注射中等剂量利尿剂；303例为对照组，由急诊医生确定护理方案。主要终点是30天时的出院存活天数。

503例患者的中位年龄为87岁，其中女性占59%，共有502例接受了分析。干预组患者在最初4小时内静脉注射硝酸盐的中位数为27.0 mg，显著高于对照组（4.0 mg）。干预组因诱发因素而接受治疗的患者占58.8%，显著高于对照组（31.9%）。两组在30天时的平均存活出院天数均为19天，没有统计学差异。在30天时，干预组和对照组的死亡率、心血管死亡率、计划外再入院率、住院时间中位数和肾脏损害率亦均无显著差异。

研究结果表明，对于老年急性心力衰竭患者，急诊室进行基于指南的综合护理，与常规护理相比，在30天存活出院天数方面并无显著优势。

附：英文原文

Title: Effect of an Emergency Department Care Bundle on 30-Day Hospital Discharge and Survival Among Elderly Patients With Acute Heart Failure: The ELISABETH Randomized Clinical Trial

Author: Yonathan Freund, Marine Cachanado, Quentin Delannoy, Said Laribi, Youri Yordanov, Judith Gorlicki, Tahar Chouihed, Anne-Laure Féral-Pierssens, Jennifer Truchot, Thibaut Desmettre, Celine Occelli, Xavier Bobbia, Mehdi Khellaf, Olivier Ganansia, Jérme Bokobza, Frédéric Balen, Sebastien Beaune, Ben Bloom, Tabassome Simon, Alexandre Mebazaa

Issue&Volume: 2020/11/17

Abstract:

Importance  Clinical guidelines for the early management of acute heart failure in the emergency department (ED) setting are based on only moderate levels of evidence, with subsequent low adherence to these guidelines.

Objective  To test the effect of an early guideline-recommended care bundle on short-term prognosis in older patients with acute heart failure in the ED.

Design, Setting, and Participants  Stepped-wedge cluster randomized trial in 15 EDs in France of 503 patients 75 years and older with a diagnosis of acute heart failure in the ED from December 2018 to September 2019 and followed up for 30 days until October 2019.

Interventions  A care bundle that included early intravenous nitrate boluses; management of precipitating factors, such as acute coronary syndrome, infection, or atrial fibrillation; and moderate dose of intravenous diuretics (n=200). In the control group, patient care was left to the discretion of the treating emergency physician (n=303). Each center was randomized to the order in which they switched to the “intervention period.” After the initial 4-week control period for all centers, 1 center entered in the intervention period every 2 weeks.

Main Outcomes and Measures  The primary end point was the number of days alive and out of hospital at 30 days. Secondary outcomes included 30-day all-cause mortality, 30-day cardiovascular mortality, unscheduled readmission, length of hospital stay, and kidney impairment.

Results  Among 503 patients who were randomized (median age, 87 years; 298 [59%] women), 502 were analyzed. In the intervention group, patients received a median (interquartile range) of 27.0 (9-54) mg of intravenous nitrates in the first 4 hours vs 4.0 (2.0-6.0) mg in the control group (adjusted difference, 23.8 [95% CI, 13.5-34.1]). There was a significantly higher percentage of patients in the intervention group treated for their precipitating factors than in the control group (58.8% vs 31.9%; adjusted difference, 31.1% [95% CI, 14.3%-47.9%]). There was no statistically significant difference in the primary end point of the number of days alive and out of hospital at 30 days (median [interquartile range], 19 [0- 24] d in both groups; adjusted difference, 1.9 [95% CI, 6.6 to 2.8]; adjusted ratio, 0.88 [95% CI, 0.64-1.21]). At 30 days, there was no significant difference between the intervention and control groups in mortality (8.0% vs 9.7%; adjusted difference, 4.1% [95% CI, 17.2% to 25.3%]), cardiovascular mortality (5.0% vs 7.4%; adjusted difference, 2.1% [95% CI, 15.5% to 19.8%]), unscheduled readmission (14.3% vs 15.7%; adjusted difference, 1.3% [95% CI, 26.3% to 23.7%]), median length of hospital stay (8 d in both groups; adjusted difference, 2.5 [95% CI, 0.9 to 5.8]), and kidney impairment (1% in both groups).

Conclusions and Relevance  Among older patients with acute heart failure, use of a guideline-based comprehensive care bundle in the ED compared with usual care did not result in a statistically significant difference in the number of days alive and out of the hospital at 30 days. Further research is needed to identify effective treatments for acute heart failure in older patients.

DOI: 10.1001/jama.2020.19378

Source: https://jamanetwork.com/journals/jama/article-abstract/2772960