Protocol for a multicenter, cluster-randomized, stepped-wedge, implementation trial of a prehospital sepsis protocol

Area of Science:

• Emergency medicine
• Critical care
• Public health

Background:

• Sepsis is a life-threatening condition requiring prompt management.
• Standardized sepsis screening is recommended in hospitals but understudied in prehospital settings.
• This trial investigates the efficacy and safety of a prehospital sepsis protocol.

Purpose of the Study:

• To assess the impact of an evidence-based sepsis protocol implemented in ambulances.
• To evaluate the clinical benefits and potential risks of prehospital sepsis screening.

Main Methods:

• A multicenter, stepped-wedge, cluster-randomized trial involving 984 participants over 24 months.
• EMS personnel will screen patients using a sepsis protocol with specific inclusion criteria (e.g., low blood pressure, high respiratory rate).
• Primary outcome: time to first antibiotic in the ED; safety outcome: antibiotic days of therapy for non-sepsis patients.

Main Results:

• Data collection ongoing; results not yet available.
• The study aims to determine if prehospital sepsis screening reduces time to antibiotic administration.
• Safety analysis will focus on antibiotic overuse in false-positive screens.

Conclusions:

• Successful completion will provide crucial data on prehospital sepsis screening.
• This research will contribute to establishing standardized prehospital sepsis care protocols.
• Findings are expected to improve early sepsis detection and management in the prehospital environment.