Sepsis, Sepsis, Severe, Septic Shock
Conditions
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.
Interventions
OTHERSepsis care bundle
Initiation of sepsis care bundle in prehospital setting, including collection of blood cultures, administration of antibiotics, and initiation of IV fluids
Sponsors
HealthPartners Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed