Sorbonne Université, IMProving Emergency Care (IMPEC) FHU, Paris, France.
Emergency Department, Hôpital Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France.
Intensive Care Med. 2024 Jul;50(7):1086-1095. doi: 10.1007/s00134-024-07509-1. Epub 2024 Jun 24.
The efficacy of the 1-h bundle for emergency department (ED) patients with suspected sepsis, which includes lactate measurement, blood culture, broad-spectrum antibiotics administration, administration of 30 mL/kg crystalloid fluid for hypotension or lactate ≥ 4 mmol/L, remains controversial.
We carried out a pragmatic stepped-wedge cluster-randomized trial in 23 EDs in France and Spain. Adult patients with Sepsis-3 criteria or a quick sequential organ failure assessment (SOFA) score ≥ 2 or a lactate > 2 mmol/L were eligible. The intervention was the implementation of the 1-h sepsis bundle. The primary outcome was in-hospital mortality truncated at 28 days. Secondary outcomes included volume of fluid resuscitation at 24 h, acute heart failure at 24 h, SOFA score at 72 h, intensive care unit (ICU) length of stay, number of days on mechanical ventilation or renal replacement therapy, vasopressor free days, unnecessary antibiotic administration, and mortality at 28 days. 1148 patients were planned to be analysed; the study period ended after 873 patients were included.
872 patients (mean age 66, 42% female) were analyzed: 387 (44.4%) in the intervention group and 485 (55.6%) in the control group. Median SOFA score was 3 [1-5]. Median time to antibiotic administration was 40 min in the intervention group vs 113 min in the control group (difference - 73 [95% confidence interval (CI) - 93 to - 53]). There was a significantly higher rate, volume, and shorter time to fluid resuscitation within 3 h in the intervention group. There were 47 (12.1%) in-hospital deaths in the intervention group compared to 61 (12.6%) in the control group (difference in percentage - 0.4 [95% CI - 5.1 to 4.2], adjusted relative risk (aRR) 0.81 [95% CI 0.48 to 1.39]). There were no differences between groups for other secondary endpoints.
Among patients with suspected sepsis in the ED, the implementation of the 1-h sepsis bundle was not associated with significant difference in in-hospital mortality. However, this study may be underpowered to report a statistically significant difference between groups.
对于疑似脓毒症的急诊科（ED）患者，1 小时捆绑包治疗方案包括测量乳酸、进行血培养、给予广谱抗生素、低血压或乳酸≥4mmol/L 时给予 30ml/kg 的晶体液、快速序贯器官衰竭评估（SOFA）评分≥2 或乳酸水平>2mmol/L，其疗效仍存在争议。
我们在法国和西班牙的 23 个 ED 中进行了一项实用的分步楔形集群随机试验。符合 Sepsis-3 标准或快速 SOFA 评分≥2 或乳酸>2mmol/L 的成年患者符合入选标准。干预措施是实施 1 小时脓毒症捆绑包。主要结局是 28 天内的院内死亡率。次要结局包括 24 小时的液体复苏量、24 小时急性心力衰竭、72 小时 SOFA 评分、重症监护病房（ICU）住院时间、机械通气或肾脏替代治疗天数、无血管加压素天数、不必要的抗生素使用以及 28 天死亡率。计划分析 1148 例患者；在纳入 873 例患者后，研究结束。
共分析了 872 例患者（平均年龄 66 岁，42%为女性）：干预组 387 例（44.4%），对照组 485 例（55.6%）。SOFA 评分中位数为 3 [1-5]。干预组抗生素使用中位时间为 40 分钟，对照组为 113 分钟（差值-73[95%置信区间（CI）-93 至-53]）。干预组在 3 小时内接受液体复苏的比例、容量和时间均显著更高。干预组院内死亡 47 例（12.1%），对照组 61 例（12.6%）（差异百分比-0.4[95%CI-5.1 至 4.2]，调整后的相对风险（aRR）0.81[95%CI 0.48 至 1.39]）。两组其他次要结局无差异。
在 ED 疑似脓毒症患者中，实施 1 小时脓毒症捆绑包治疗方案与院内死亡率无显著差异。然而，本研究可能在报告组间统计学显著差异方面能力不足。
