NCT04134624

EMS Prehospital Blood Culture Collection and Antibiotic Administration: A Two-Phase Pilot Project to Reduce Mortality in Patients With Severe Sepsis and Septic Shock

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 215 (actual)
• Sponsor: HealthPartners Institute · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to improve the outcomes for patients suffering from severe sepsis and septic shock (SS/SS) by decreasing the time from first medical contact to antibiotic administration. This is a stepwise study that aims to demonstrate the ability of paramedics to accurately obtain blood cultures prior to hospital arrival, administer a broad spectrum antibiotic and initiate IV fluid resuscitation in patients meeting predefined criteria for SS/SS.

Detailed description

This study is designed to improve the outcomes for patients suffering from severe sepsis and septic shock (SS/SS) by decreasing the time from first medical contact to antibiotic administration. This is a pilot project. This is a stepwise study that will build on previously published literature to demonstrate the ability of paramedics to accurately obtain blood cultures prior to hospital arrival, administer a broad spectrum antibiotic and initiate IV fluid resuscitation in patients meeting predefined criteria for SS/SS. The primary aim is to take processes that have been developed for use in this patient population during Emergency Department care and to advance these same processes "downrange" to initiate them prior to hospital arrival. Early antibiotic administration has been shown to decrease mortality in a time dependent fashion when implemented in hospitalized patients. The investigators hypothesize that initiating antibiotics prior to hospital arrival will improve morbidity and mortality while also addressing quality metrics that are publicly reported for this patient population. This pilot study will be conducted in two consecutive phases, responding to the following aims. Aim 1: Evaluate the feasibility that paramedics can obtain blood cultures from general patients prior to hospital arrival with a contamination rate that is statistically equivalent to that for blood cultures obtained in Emergency Department. Aim 2 (primary aim): Investigate whether prehospital paramedic initiated broad spectrum antibiotics, administered after blood cultures are obtained, will result in improved mortality rates for patients, when compared to historical controls.

Conditions

• Sepsis
• Sepsis, Severe
• Septic Shock

Interventions

Type	Name	Description
OTHER	Sepsis care bundle	Initiation of sepsis care bundle in prehospital setting, including collection of blood cultures, administration of antibiotics, and initiation of IV fluids

Timeline

• Start date: 2019-09-11
• Primary completion: 2020-02-27
• Completion: 2021-07-08
• First posted: 2019-10-22
• Last updated: 2021-09-22

Locations

1 site across 1 country: United States