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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sepsis, Sepsis, Severe, Septic Shock

Intervention / Treatment
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* Other: Sepsis care bundle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Phase 1 (blood culture contamination rate quantification phase) 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. 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: Patients age <18 years Hemodynamic instability Prisoners Phase 2: Documented allergy to Penicillin or inability to determine patient's medication allergies Prisoners Pregnant patients Patients being transferred from one hospital to another Non-English speakers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: This is a stepwise study with two phases. In phase 1, all eligible patients have a blood culture collected. In phase 2, eligible patients have a blood culture collected and antibiotics started in the prehospital setting.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prehospital intervention<br>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. | Other: Sepsis care bundle<br>* Initiation of sepsis care bundle in prehospital setting, including collection of blood cultures, administration of antibiotics, and initiation of IV fluids<br>|
| No Intervention: Control arm<br>Historical controls without prehospital sepsis intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In hospital mortality | Mortality during hospital admission following enrollment | Through duration of hospitalization, average 1 week | 
| ICU length of stay | Length of stay in ICU during hospital admission following enrollment | Through duration of ICU stay, average 3 days | 
| Hospital length of stay | Length of stay of hospitalization following enrollment | Through duration of hospitalization, average 1 week | 
| 30 day mortality | Mortality 30 days following enrollment | 30 days |