ArticleTrials2025
Protocol for a multicenter, cluster-randomized, stepped-wedge, implementation trial of a prehospital sepsis protocol.
Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05502107 (A Multicenter, Stepped Wedge, Cluster Randomized Study of a Prehospital Sepsis Protocol and Its Impact on Timely Antibiotic Administration in the Emergency Department and Subsequent Adverse Events), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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A Multicenter, Stepped Wedge, Cluster Randomized Study of a Prehospital Sepsis Protocol and Its Impact on Timely Antibiotic Administration in the Emergency Department and Subsequent Adverse Events
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0 citing papers in PubMed.
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Authors and funding
20 authors.
Funding
Abstract
backgroundSepsis is a common, life-threatening medical emergency in which early recognition and treatment are cornerstones of management. Best practice guidelines recommend standardized sepsis screening in hospitals to facilitate early recognition. In contrast, very little is known about the efficacy and safety of standardized sepsis screening in the prehospital Emergency Medical Services (EMS) environment. To help address this knowledge gap, this study protocol will evaluate the impact of implementing an evidence-based sepsis protocol in ambulances.
methodsWe plan to conduct a multicenter, stepped-wedge, cluster-randomized trial at 3 sites and enroll 984 participants over 24 months. EMS personnel will be trained to screen all eligible EMS patients using a sepsis screening and early notification protocol. Study inclusion criteria include all the following: (1) EMS systolic blood pressure < 110 mmHg, (2) EMS pulse > 90 beats/min, (3) EMS respiratory rate > 20 breaths/min, and (4) a positive sepsis screen based on the EMS sepsis protocol. To evaluate the clinical impact of the EMS sepsis protocol on patient care, the primary outcome is time to first antibiotic administration in the ED (emergency department) among patients with sepsis (a key treatment intervention in patients with sepsis). To evaluate the potential risk of the EMS sepsis protocol, the surrogate primary safety outcome is the total number of antibiotic DOT (days of therapy) during the first 7 days of hospitalization among patients without sepsis (i.e., false positive sepsis screens). DISCUSSION: Successful completion of this trial will expand our understanding of prehospital sepsis screening as a standardized approach to prehospital sepsis care.
trial registrationClinicalTrials.gov Identifier: NCT05502107. Date of first posting: 08-16-2022. https://clinicaltrials.gov/ct2/show/NCT05502107 .
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