Journal article
Protocol for a multicenter, cluster-randomized, stepped-wedge, implementation trial of a prehospital sepsis protocol
Trials, Vol.26(1), 491
11/11/2025
DOI: 10.1186/s13063-025-09172-3
PMCID: PMC12607186
PMID: 41220003
Abstract
Background
Sepsis 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.
Methods
We 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.
Details
- Title: Subtitle
- Protocol for a multicenter, cluster-randomized, stepped-wedge, implementation trial of a prehospital sepsis protocol
- Creators
- Shamie Das - Emory UniversityAzeemuddin Ahmed - University of IowaOlga Capurro - Emory UniversityMichael J Carr - Emory UniversityFabiana Barerro Castedo - Emory UniversityScott K Fridkin - Emory UniversityAlex Hall - Emory UniversityStacey House - Washington University in St. LouisJoseph Kellogg - Emory UniversityMelissa Kroll - Washington University in St. LouisNicholas Kurtzman - Emory UniversityRajashri Manjunath - Emory UniversityC Christina Mehta - Emory UniversityNicholas M Mohr - University of IowaRadhika Prakash-Asrani - Emory University School of MedicineCaroline C Rudolph - Emory UniversityChristine Spainhour - Emory UniversityTwinkle Trehan - Emory UniversityJonathan E Sevransky - Emory UniversityCarmen C Polito - Emory University
- Resource Type
- Journal article
- Publication Details
- Trials, Vol.26(1), 491
- DOI
- 10.1186/s13063-025-09172-3
- PMID
- 41220003
- PMCID
- PMC12607186
- NLM abbreviation
- Trials
- ISSN
- 1745-6215
- eISSN
- 1745-6215
- Publisher
- BioMed Central
- Grant note
- U54CK000601-01-01 / CDC HHS U54 CK000601 / NCEZID CDC HHS
- Language
- English
- Date published
- 11/11/2025
- Academic Unit
- Epidemiology; Emergency Medicine; Anesthesia; Injury Prevention Research Center
- Record Identifier
- 9985027356502771
Metrics
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