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

NCT ID: NCT04134624

Last Updated: 2021-09-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 215 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-11
• Study Completion Date: 2021-07-08

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.

Conditions

Sepsis; Sepsis, Severe; Septic Shock

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Sepsis care bundle

Intervention Type: OTHER

Initiation of sepsis care bundle in prehospital setting, including collection of blood cultures, administration of antibiotics, and initiation of IV fluids

Control arm

Historical controls without prehospital sepsis intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sepsis care bundle

Initiation of sepsis care bundle in prehospital setting, including collection of blood cultures, administration of antibiotics, and initiation of IV fluids

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HealthPartners Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aaron Burnett, MD

Role: PRINCIPAL_INVESTIGATOR

HealthPartners Institute

Locations

Lakeview Hospital

Stillwater, Minnesota, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 27452768 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28114603 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16362889 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24717459 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28345952 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20048677 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11794169 (View on PubMed)

Mouncey PR, Osborn TM, Power GS, Harrison DA, Sadique MZ, Grieve RD, Jahan R, Harvey SE, Bell D, Bion JF, Coats TJ, Singer M, Young JD, Rowan KM; ProMISe Trial Investigators. Trial of early, goal-directed resuscitation for septic shock. N Engl J Med. 2015 Apr 2;372(14):1301-11. doi: 10.1056/NEJMoa1500896. Epub 2015 Mar 17.

Reference Type: BACKGROUND

PMID: 25776532 (View on PubMed)

Peake SL, Delaney A, Bellomo R; ARISE Investigators. Goal-directed resuscitation in septic shock. N Engl J Med. 2015 Jan 8;372(2):190-1. doi: 10.1056/NEJMc1413936. No abstract available.

Reference Type: BACKGROUND

PMID: 25564906 (View on PubMed)

Lane D, Ichelson RI, Drennan IR, Scales DC. Prehospital management and identification of sepsis by emergency medical services: a systematic review. Emerg Med J. 2016 Jun;33(6):408-13. doi: 10.1136/emermed-2015-205261. Epub 2016 Feb 10.

Reference Type: BACKGROUND

PMID: 26864327 (View on PubMed)

Walchok JG, Pirrallo RG, Furmanek D, Lutz M, Shope C, Giles B, Gue G, Dix A. Paramedic-Initiated CMS Sepsis Core Measure Bundle Prior to Hospital Arrival: A Stepwise Approach. Prehosp Emerg Care. 2017 May-Jun;21(3):291-300. doi: 10.1080/10903127.2016.1254694. Epub 2016 Dec 5.

Reference Type: BACKGROUND

PMID: 27918869 (View on PubMed)

Other Identifiers

A19-118

Identifier Type: -

Identifier Source: org_study_id