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

NCT04134624 | Terminated

• 1 other identifier: A19-118
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Sepsis, Severe; Septic Shock

Outcome Measures

Primary Outcomes (4)

• In hospital mortality

  Mortality during hospital admission following enrollment

  Through duration of hospitalization, average 1 week

• ICU length of stay

  Length of stay in ICU during hospital admission following enrollment

  Through duration of ICU stay, average 3 days

• Hospital length of stay

  Length of stay of hospitalization following enrollment

  Through duration of hospitalization, average 1 week

• 30 day mortality

  Mortality 30 days following enrollment

  30 days

Study Arms (2)

Prehospital intervention

ACTIVE COMPARATOR

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

Control arm

NO INTERVENTION

Historical controls without prehospital sepsis intervention.

Interventions

Sepsis care bundle OTHER

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

Prehospital intervention

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HealthPartners Institute: lead

Study Sites (1)

Lakeview Hospital

Stillwater, Minnesota, 55082, United States

Location

Related Publications (11)

• 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.

  PMID: 27452768 BACKGROUND

• 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.

  PMID: 28114603 BACKGROUND

• 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.

  PMID: 16362889 BACKGROUND

• 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.

  PMID: 24717459 BACKGROUND

• 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.

  PMID: 28345952 BACKGROUND

• 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.

  PMID: 20048677 BACKGROUND

• 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.

  PMID: 11794169 BACKGROUND

• 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.

  PMID: 25776532 BACKGROUND

• 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.

  PMID: 25564906 BACKGROUND

• 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.

  PMID: 26864327 BACKGROUND

• 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.

  PMID: 27918869 BACKGROUND

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Aaron Burnett, MD

  HealthPartners Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 22, 2019
• Study Start: September 11, 2019
• Primary Completion: February 27, 2020
• Study Completion: July 8, 2021
• Last Updated: September 22, 2021

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)