Clinical trial 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
Official title: 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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sepsis
Sepsis, Severe
Septic Shock
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
First posted: 2019-10-22
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: In hospital mortality
timeFrame: Through duration of hospitalization, average 1 week
measure: ICU length of stay
timeFrame: Through duration of ICU stay, average 3 days
measure: Hospital length of stay
timeFrame: Through duration of hospitalization, average 1 week
measure: 30 day mortality
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Stillwater
country: United States
facility: Lakeview Hospital
state: Minnesota
Study officials:
affiliation: HealthPartners Institute
name: Aaron Burnett, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kadri SS, Rhee C, Strich JR, Morales MK, Hohmann S, Menchaca J, Suffredini AF, Danner RL, Klompas M. Estimating Ten-Year Trends in Septic Shock Incidence and Mortality in United States Academic Medical Centers Using Clinical Data. Chest. 2017 Feb;151(2):278-285. doi: 10.1016/j.chest.2016.07.010. Epub 2016 Jul 22.
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citation: Gaieski DF, Mikkelsen ME, Band RA, Pines JM, Massone R, Furia FF, Shofer FS, Goyal M. Impact of time to antibiotics on survival in patients with severe sepsis or septic shock in whom early goal-directed therapy was initiated in the emergency department. Crit Care Med. 2010 Apr;38(4):1045-53. doi: 10.1097/CCM.0b013e3181cc4824.
citation: Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. doi: 10.1056/NEJMoa010307.
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