Department of Psychiatry and Human Behavior, The Warren Alpert Medical School of Brown University, Providence, RI, USA.
Division of Pulmonary, Critical Care and Sleep Medicine, University of Washington, Seattle, WA, USA.
Trials. 2023 Sep 29;24(1):620. doi: 10.1186/s13063-023-07644-y.
Sepsis is the leading cause of intensive care unit (ICU) admission and ICU death. In recognition of the burden of sepsis, the Surviving Sepsis Campaign (SSC) and the Institute for Healthcare Improvement developed sepsis "bundles" (goals to accomplish over a specific time period) to facilitate SSC guideline implementation in clinical practice. Using the SSC 3-h bundle as a base, the Centers for Medicare and Medicaid Services developed a 3-h sepsis bundle that has become the national standard for early management of sepsis. Emerging observational data, from an analysis conducted for the AIMS grant application, suggest there may be additional mortality benefit from even earlier implementation of the 3-h bundle, i.e., the 1-h bundle.
The primary aims of this randomized controlled trial are to: (1) examine the effect on clinical outcomes of Emergency Department initiation of the elements of the 3-h bundle within the traditional 3 h versus initiating within 1 h of sepsis recognition and (2) examine the extent to which a rigorous implementation strategy will improve implementation and compliance with both the 1-h bundle and the 3-h bundle. This study will be entirely conducted in the Emergency Department at 18 sites. A secondary aim is to identify clinical sepsis phenotypes and their impact on treatment outcomes.
This cluster-randomized trial, employing implementation science methodology, is timely and important to the field. The hybrid effectiveness-implementation design is likely to have an impact on clinical practice in sepsis management by providing a rigorous evaluation of the 1- and 3-h bundles.
NHLBI R01HL162954.
ClinicalTrials.gov NCT05491941. Registered on August 8, 2022.
脓毒症是重症监护病房（ICU）入住和 ICU 死亡的主要原因。为了认识到脓毒症的负担，拯救脓毒症运动（SSC）和医疗保健改进研究所制定了脓毒症“捆绑包”（在特定时间段内完成的目标），以促进 SSC 指南在临床实践中的实施。以 SSC 3 小时捆绑包为基础，医疗保险和医疗补助服务中心制定了一个 3 小时脓毒症捆绑包，该捆绑包已成为脓毒症早期管理的国家标准。来自 AIMS 资助申请分析的新观察数据表明，更早地实施 3 小时捆绑包（即 1 小时捆绑包）可能会带来更多的死亡率益处。
这项随机对照试验的主要目的是：（1）检查在急诊科，与传统的 3 小时内开始实施 3 小时捆绑包的各个元素相比，在识别脓毒症后 1 小时内开始实施这些元素对临床结果的影响；（2）检查严格的实施策略将如何提高对 1 小时捆绑包和 3 小时捆绑包的实施和遵守程度。这项研究将完全在 18 个地点的急诊科进行。次要目标是确定临床脓毒症表型及其对治疗结果的影响。
这项采用实施科学方法的聚类随机试验，对该领域来说是及时和重要的。混合有效性-实施设计很可能通过对 1 小时和 3 小时捆绑包进行严格评估，对脓毒症管理的临床实践产生影响。
NHLBI R01HL162954。
ClinicalTrials.gov NCT05491941。于 2022 年 8 月 8 日注册。
