EMS Prehospital Blood Culture Collection and Antibiotic Administration: A Two-Phase Pilot Project to Reduce Mortality in Patients With Severe Sepsis and Septic Shock
|ClinicalTrials.gov Identifier: NCT04134624|
Recruitment Status : Enrolling by invitation
First Posted : October 22, 2019
Last Update Posted : October 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Sepsis Sepsis, Severe Septic Shock||Other: Sepsis care bundle||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||534 participants|
|Intervention Model:||Single Group Assignment|
|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.|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||September 11, 2019|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||February 2021|
Active Comparator: Prehospital intervention
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
Initiation of sepsis care bundle in prehospital setting, including collection of blood cultures, administration of antibiotics, and initiation of IV fluids
No Intervention: Control arm
Historical controls without prehospital sepsis intervention.
- In hospital mortality [ Time Frame: Through duration of hospitalization, average 1 week ]Mortality during hospital admission following enrollment
- ICU length of stay [ Time Frame: Through duration of ICU stay, average 3 days ]Length of stay in ICU during hospital admission following enrollment
- Hospital length of stay [ Time Frame: Through duration of hospitalization, average 1 week ]Length of stay of hospitalization following enrollment
- 30 day mortality [ Time Frame: 30 days ]Mortality 30 days following enrollment
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04134624
|United States, Minnesota|
|Stillwater, Minnesota, United States, 55082|
|Principal Investigator:||Aaron Burnett, MD||HealthPartners Institute|