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

Not Applicable

Terminated

• Conditions: Sepsis, Severe; Sepsis; Septic Shock
• Interventions: Other: Sepsis care bundle

• Registration Number: NCT04134624
• Lead Sponsor: HealthPartners Institute

Brief 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.

Study Timeline

• Study Start: 2019-09-11
• Status Verified: 2019-10
• Study First Submitted: 2019-10-16
• Study First Submitted QC: 2019-10-18
• Study First Posted: 2019-10-22
• Primary Completion: 2020-02-27
• Study Completion: 2021-07-08
• Last Update Submitted: 2021-09-16
• Last Update Posted: 2021-09-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 215

Inclusion Criteria

Phase 1 (blood culture contamination rate quantification phase)

1. Hemodynamically stable patients ≥18 years old being transported by Lakeview EMS to Lakeview Hospital who will have an intravenous access established as part of their routine prehospital care are eligible for this study.
2. English speaker

Phase 2 (blood cultures + antibiotics prehospital)

a. Patients with fever >38oC + ≥2 qSOFA who are being transported to Lakeview Hospital that originate as a 911 call

Exclusion Criteria

Phase 1:

1. Patients age <18 years
2. Hemodynamic instability
3. Prisoners

Phase 2:

1. Documented allergy to Penicillin or inability to determine patient's medication allergies
2. Prisoners
3. Pregnant patients
4. Patients being transferred from one hospital to another
5. Non-English speakers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prehospital intervention	Sepsis care bundle	All subjects enrolled in this study will receive a sepsis intervention bundle in the prehospital setting, including blood cultures, IV fluids, and antibiotics. These patients will be compared to historical controls.

Primary Outcome Measures

Name	Time	Method
In hospital mortality	Through duration of hospitalization, average 1 week	Mortality during hospital admission following enrollment
ICU length of stay	Through duration of ICU stay, average 3 days	Length of stay in ICU during hospital admission following enrollment
Hospital length of stay	Through duration of hospitalization, average 1 week	Length of stay of hospitalization following enrollment
30 day mortality	30 days	Mortality 30 days following enrollment

Trial Locations

Locations (1)

Lakeview Hospital; 🇺🇸 Stillwater, Minnesota, United States