EMS Prehospital Blood Culture Collection and Antibiotic Administration: A Two-Phase Pilot Project to Reduce Mortality in Patients With Severe Sepsis and Septic Shock
Primary Purpose
Sepsis, Sepsis, Severe, Septic Shock
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sepsis care bundle
Sponsored by
About this trial
This is an interventional treatment trial for Sepsis
Eligibility Criteria
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
Sites / Locations
- Lakeview Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Prehospital intervention
Control arm
Arm Description
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.
Historical controls without prehospital sepsis intervention.
Outcomes
Primary Outcome Measures
In hospital mortality
Mortality during hospital admission following enrollment
ICU length of stay
Length of stay in ICU during hospital admission following enrollment
Hospital length of stay
Length of stay of hospitalization following enrollment
30 day mortality
Mortality 30 days following enrollment
Secondary Outcome Measures
Full Information
NCT ID
NCT04134624
First Posted
October 16, 2019
Last Updated
September 16, 2021
Sponsor
HealthPartners Institute
1. Study Identification
Unique Protocol Identification Number
NCT04134624
Brief 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
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
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Terminated
Why Stopped
Recruitment for this study was halted in February 2020 due to the COVID-19 pandemic. The study team was unable to continue enrollment due to decreased volumes (and the fact that COVID-19 mimics some of the signs and symptoms of severe sepsis)
Study Start Date
September 11, 2019 (Actual)
Primary Completion Date
February 27, 2020 (Actual)
Study Completion Date
July 8, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HealthPartners Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Sepsis, Severe, Septic Shock
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
Non-Randomized
Enrollment
215 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prehospital intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
Historical controls without prehospital sepsis intervention.
Intervention Type
Other
Intervention Name(s)
Sepsis care bundle
Intervention Description
Initiation of sepsis care bundle in prehospital setting, including collection of blood cultures, administration of antibiotics, and initiation of IV fluids
Primary Outcome Measure Information:
Title
In hospital mortality
Description
Mortality during hospital admission following enrollment
Time Frame
Through duration of hospitalization, average 1 week
Title
ICU length of stay
Description
Length of stay in ICU during hospital admission following enrollment
Time Frame
Through duration of ICU stay, average 3 days
Title
Hospital length of stay
Description
Length of stay of hospitalization following enrollment
Time Frame
Through duration of hospitalization, average 1 week
Title
30 day mortality
Description
Mortality 30 days following enrollment
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron Burnett, MD
Organizational Affiliation
HealthPartners Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lakeview Hospital
City
Stillwater
State/Province
Minnesota
ZIP/Postal Code
55082
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27452768
Citation
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Results Reference
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PubMed Identifier
28114603
Citation
Howell MD, Davis AM. Management of Sepsis and Septic Shock. JAMA. 2017 Feb 28;317(8):847-848. doi: 10.1001/jama.2017.0131. No abstract available.
Results Reference
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PubMed Identifier
16362889
Citation
Kumar A, Haery C, Paladugu B, Kumar A, Symeoneides S, Taiberg L, Osman J, Trenholme G, Opal SM, Goldfarb R, Parrillo JE. The duration of hypotension before the initiation of antibiotic treatment is a critical determinant of survival in a murine model of Escherichia coli septic shock: association with serum lactate and inflammatory cytokine levels. J Infect Dis. 2006 Jan 15;193(2):251-8. doi: 10.1086/498909. Epub 2005 Dec 13.
Results Reference
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PubMed Identifier
24717459
Citation
Ferrer R, Martin-Loeches I, Phillips G, Osborn TM, Townsend S, Dellinger RP, Artigas A, Schorr C, Levy MM. Empiric antibiotic treatment reduces mortality in severe sepsis and septic shock from the first hour: results from a guideline-based performance improvement program. Crit Care Med. 2014 Aug;42(8):1749-55. doi: 10.1097/CCM.0000000000000330.
Results Reference
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PubMed Identifier
28345952
Citation
Liu VX, Fielding-Singh V, Greene JD, Baker JM, Iwashyna TJ, Bhattacharya J, Escobar GJ. The Timing of Early Antibiotics and Hospital Mortality in Sepsis. Am J Respir Crit Care Med. 2017 Oct 1;196(7):856-863. doi: 10.1164/rccm.201609-1848OC.
Results Reference
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PubMed Identifier
20048677
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.
Results Reference
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PubMed Identifier
11794169
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.
Results Reference
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PubMed Identifier
25776532
Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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Citation
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Results Reference
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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
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