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疑似肺炎抗生素限制使用的试验:外科感染学会多中心试点研究。

Trial of antibiotic restraint in presumed pneumonia: A Surgical Infection Society multicenter pilot.

机构信息

From the Department of Surgery (C.A.G., J.C.O.), University of Kansas Medical Center, Kansas City, Kansas; Department of Surgery (R.T.B., M.D.), Vanderbilt University Medical Center, Nashville, Tennessee; Department of Surgery (C.M.W.), Prisma Health Midlands, Columbia, South Carolina; Department of Surgery (R.G.S.), Western Michigan Homer Stryker M.D. School of Medicine, Kalamazoo, Michigan; Department of Biostatistics and Data Science (L.C.-H.) and Department of Medicine (S.Q.S.), University of Kansas Medical Center, Kansas City, Kansas; Department of Pharmaceutical Services (L.A.), Vanderbilt University Medical Center, Nashville, Tennessee; Department of Pharmaceutical Services (L.C.C.), Prisma Health Midlands, Columbia, South Carolina; Department of Surgery (G.P.P.), Florida State University School of Medicine, Tallahassee Memorial Healthcare, Tallahassee, Florida; Department of Surgery (S.V.), Division of Trauma Surgery, Bronson Methodist Hospital, Kalamazoo, Michigan; and Department of Surgery (B.N.H.), Boston University Medical Center, Boston, Massachusetts.

出版信息

J Trauma Acute Care Surg. 2023 Feb 1;94(2):232-240. doi: 10.1097/TA.0000000000003839. Epub 2022 Nov 18.

DOI:10.1097/TA.0000000000003839
PMID:36534474
Abstract

BACKGROUND

Pneumonia is the most common intensive care unit-acquired infection in the trauma and emergency general surgery population. Despite guidelines urging rapid antibiotic use, data supporting immediate antibiotic initiation in cases of suspected infection are limited. Our hypothesis was that a protocol of specimen-initiated antibiotic initiation would have similar compliance and outcomes to an immediate initiation protocol.

METHODS

We devised a pragmatic cluster-randomized crossover pilot trial. Four surgical and trauma intensive care units were randomized to either an immediate initiation or specimen-initiated antibiotic protocol for intubated patients with suspected pneumonia and bronchoscopically obtained cultures who did not require vasopressors. In the immediate initiation arm, antibiotics were started immediately after the culture regardless of patient status. In the specimen-initiated arm, antibiotics were delayed until objective Gram stain or culture results suggested infection. Each site participated in both arms after a washout period and crossover. Outcomes were protocol compliance, all-cause 30-day mortality, and ventilator-free alive days at 30 days. Standard statistical techniques were applied.

RESULTS

A total of 186 patients had 244 total cultures, of which only the first was analyzed. Ninety-three patients (50%) were enrolled in each arm, and 94.6% were trauma patients (84.4% blunt trauma). The median age was 50.5 years, and 21% of the cohort was female. There were no differences in demographics, comorbidities, sequential organ failure assessment, Acute Physiology and Chronic Health Evaluation II, or Injury Severity Scores. Antibiotics were started significantly later in the specimen-initiated arm (0 vs. 9.3 hours; p < 0.0001) with 19.4% avoiding antibiotics completely for that episode. There were no differences in the rate of protocol adherence, 30-day mortality, or ventilator-free alive days at 30 days.

CONCLUSION

In this cluster-randomized crossover trial, we found similar compliance rates between immediate and specimen-initiated antibiotic strategies. Specimen-initiated antibiotic protocol in patients with a suspected hospital-acquired pneumonia did not result in worse clinical outcomes compared with immediate initiation.

LEVEL OF EVIDENCE

Therapeutic/Care Management; Level II.

摘要

背景

肺炎是创伤和急诊普通外科患者在重症监护病房中最常见的获得性感染。尽管指南敦促快速使用抗生素,但支持疑似感染立即开始使用抗生素的数据有限。我们的假设是,标本启动抗生素起始的方案与立即起始方案具有相似的依从性和结果。

方法

我们设计了一个实用的聚类随机交叉试验。四个外科和创伤重症监护病房被随机分配到立即起始或标本起始抗生素方案,用于疑似肺炎和支气管镜获得培养物的插管患者,这些患者不需要升压药。在立即起始组中,无论患者状况如何,在培养后立即开始使用抗生素。在标本起始组中,抗生素延迟到革兰氏染色或培养结果提示感染时才开始使用。每个站点在洗脱期和交叉后都参与了两个臂。结果是方案依从性、全因 30 天死亡率和 30 天无呼吸机存活天数。应用了标准统计技术。

结果

共有 186 名患者进行了 244 次总培养,仅对第一次进行了分析。每组有 93 名患者(50%)入组,94.6%为创伤患者(84.4%为钝性创伤)。中位年龄为 50.5 岁,21%的患者为女性。两组在人口统计学、合并症、序贯器官衰竭评估、急性生理学和慢性健康评估 II 以及损伤严重程度评分方面没有差异。标本起始组抗生素开始时间明显延迟(0 小时与 9.3 小时;p<0.0001),19.4%的患者完全避免了该次发作的抗生素。方案依从率、30 天死亡率或 30 天无呼吸机存活天数无差异。

结论

在这项聚类随机交叉试验中,我们发现立即和标本起始抗生素策略之间的依从率相似。与立即起始相比,疑似医院获得性肺炎患者的标本起始抗生素方案并未导致临床结局恶化。

证据水平

治疗/护理管理;二级。

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