SepsisNCT04134624

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

A study testing Sepsis care bundle in people with Sepsis and Sepsis, Severe, run by HealthPartners Institute at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Sepsis, Sepsis, Severe, Septic Shock
What is being tested?: Sepsis care bundle
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 215 participants
Where: 1 siteUnited States
Study dates: 11 Sep 2019to 8 Jul 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)
Patients with fever >38oC + ≥2 qSOFA who are being transported to Lakeview Hospital that originate as a 911 call

Who cannot join

Phase 1:
Patients age <18 years
Hemodynamic instability
Prisoners
Phase 2:
Documented allergy to Penicillin or inability to determine patient's medication allergies

Show all 10Show fewer

Prisoners
Pregnant patients
Patients being transferred from one hospital to another
Non-English speakers

Trial locations and contacts

1 site in 1 country.

United States1 site

Lakeview Hospital
Stillwater, Minnesota, 55082

Other trials in United States

About this study

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.

Read the 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
Being tested: Sepsis care bundle
Medical subject headings: Sepsis, Shock, Septic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04134624
Study group	Role	What they receive
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. Receives: Other: Sepsis care bundle
Control arm	No intervention	Historical controls without prehospital sepsis intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

In hospital mortality
Mortality during hospital admission following enrollment
Measured: Through duration of hospitalization, average 1 week
ICU length of stay
Length of stay in ICU during hospital admission following enrollment
Measured: Through duration of ICU stay, average 3 days
Hospital length of stay
Length of stay of hospitalization following enrollment
Measured: Through duration of hospitalization, average 1 week
30 day mortality
Mortality 30 days following enrollment
Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Sep 20198 Jul 2021

First posted22 Oct 2019
Study start11 Sep 2019
Primary completion27 Feb 2020
Study completion8 Jul 2021

Why it 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)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for SepsisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
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)
Enrolment: 215 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04134624
Sponsor's protocol ID: A19-118
Status last verified: Oct 2019
First submitted: 16 Oct 2019
Last updated: 22 Sep 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 27452768
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.
PubMed 28114603
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.
PubMed 16362889
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.
PubMed 24717459
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.
PubMed 28345952
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.
PubMed 20048677
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.
PubMed 11794169
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.
PubMed 25776532
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.
PubMed 25564906
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.
PubMed 26864327
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.
PubMed 27918869

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Sepsis trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04134624
Acronym / sponsor ID: A19-118
Conditions: Sepsis, Sepsis, Severe, Septic Shock
Study type: Interventional
Recruitment status: TerminatedReason 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)
Enrolment: 215 participants (actual)
Lead sponsor: HealthPartners InstituteUniversity, hospital or other
Study start: 11 Sep 2019 (actual)
Primary completion: 27 Feb 2020 (actual)
Study completion: 8 Jul 2021 (actual)
First posted: 22 Oct 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
Prehospital intervention	Active comparator	Other: Sepsis care bundleAll 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.
Control arm	No intervention	–Historical controls without prehospital sepsis intervention.

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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)
Patients with fever >38oC + ≥2 qSOFA who are being transported to Lakeview Hospital that originate as a 911 call

Key exclusion criteria (10 listed)

Patients age <18 years
Hemodynamic instability
Prisoners
Documented allergy to Penicillin or inability to determine patient's medication allergies
Prisoners

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sepsis care bundleInitiation of sepsis care bundle in prehospital setting, including collection of blood cultures, administration of antibiotics, and initiation of IV fluids	Other	Prehospital intervention

Primary outcome

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

Results and safety

The study was stopped early (reason given: 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)). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
Background: PubMed 27452768Kadri 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.
Background: PubMed 28114603Howell 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.
Background: PubMed 16362889Kumar 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.
Background: PubMed 24717459Ferrer 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.
Background: PubMed 28345952Liu 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.
Background: PubMed 20048677Gaieski 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.
Background: PubMed 11794169Rivers 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.
Background: PubMed 25776532Mouncey 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.
Background: PubMed 25564906Peake 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.
Background: PubMed 26864327Lane 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.
Background: PubMed 27918869Walchok 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.
Individual participant dataSharing planned: No

Related trials for Sepsis

Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Aaron Burnett, MD principal investigator

HealthPartners Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Sepsis care bundle in people with Sepsis and Sepsis, Severe, run by HealthPartners Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In hospital mortality (time frame: Through duration of hospitalization, average 1 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04134624, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2021.