NCT03919851

Brief Summary

Sepsis is estimated to affect more than 30 million people globally. Detecting sepsis is notoriously difficult and there are no systems in place utilize prehospitally. In Denmark, the Mobile Emergency Care Unit (the MECU), manned by a physician and paramedic, is able to draw blood cultures and take venous lactate measurements before administering antibiotics. This study aims to conduct a quality control on the ability of the MECU to recognize and treat sepsis by confirming the amounts of in-hospitally diagnosed cases. Furthermore the study investigates whether the blood cultures falls within an acceptable range of contamination.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 31, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 18, 2019

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

4 months

First QC Date

April 16, 2019

Last Update Submit

April 16, 2019

Conditions

Keywords

Prehospital recognition and treatment

Outcome Measures

Primary Outcomes (1)

  • Prehospital diagnosis confirmed

    Prehospital tentative diagnosis matches inhospital diagnosis

    Up to 30 days

Secondary Outcomes (2)

  • Blood culture positive

    First day of admission

  • Blood culture contamination below 5%

    6 days

Interventions

Administration of antibiotics

Also known as: Blood culture

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients treated by the MECU in Odense from November 1st 2013 to October 31st 2018

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mobile Emergency Care Unit in Odense

Odense, 5000, Denmark

Location

Related Publications (9)

  • Perner A, Lassen AT, Schierbeck J, Storgaard M, Reiter N, Benfield T. [Disease burden and definition of sepsis in adults]. Ugeskr Laeger. 2018 Apr 9;180(15):V09170685. Danish.

  • Seymour CW, Kahn JM, Martin-Gill C, Callaway CW, Yealy DM, Scales D, Angus DC. Delays From First Medical Contact to Antibiotic Administration for Sepsis. Crit Care Med. 2017 May;45(5):759-765. doi: 10.1097/CCM.0000000000002264.

  • Moore C, Bulger J, Morgan M, Driscoll T, Porter A, Islam S, Smyth M, Perkins G, Sewell B, Rainer T, Nanayakkara P, Okolie C, Allen S, Fegan G, Davies J, Foster T, Francis N, Smith FG, Ellis G, Shanahan T, Howe R, Snooks H. Prehospital recognition and antibiotics for 999 patients with sepsis: protocol for a feasibility study. Pilot Feasibility Stud. 2018 Mar 12;4:64. doi: 10.1186/s40814-018-0258-8. eCollection 2018.

  • Smyth MA, Brace-McDonnell SJ, Perkins GD. Impact of Prehospital Care on Outcomes in Sepsis: A Systematic Review. West J Emerg Med. 2016 Jul;17(4):427-37. doi: 10.5811/westjem.2016.5.30172. Epub 2016 Jul 5.

  • Guerra WF, Mayfield TR, Meyers MS, Clouatre AE, Riccio JC. Early detection and treatment of patients with severe sepsis by prehospital personnel. J Emerg Med. 2013 Jun;44(6):1116-25. doi: 10.1016/j.jemermed.2012.11.003. Epub 2013 Jan 13.

  • Joynes EL, Martin J, Ross M. Management of Septic Shock in the Remote Prehospital Setting. Air Med J. 2016 Jul-Aug;35(4):235-8. doi: 10.1016/j.amj.2016.04.001. Epub 2016 May 24.

  • Bodilsen J, Dalager-Pedersen M, Schonheyder HC, Nielsen H. Time to antibiotic therapy and outcome in bacterial meningitis: a Danish population-based cohort study. BMC Infect Dis. 2016 Aug 9;16:392. doi: 10.1186/s12879-016-1711-z.

  • Andersson H, Axelsson C, Larsson A, Bremer A, Gellerstedt M, Bang A, Herlitz J, Ljungstrom L. The early chain of care in bacteraemia patients: Early suspicion, treatment and survival in prehospital emergency care. Am J Emerg Med. 2018 Dec;36(12):2211-2218. doi: 10.1016/j.ajem.2018.04.004. Epub 2018 Apr 5.

  • Justesen US, Larsen BW, Eshoj O, Sogaard P. [Blood cultures--indication and antibiotic therapy]. Ugeskr Laeger. 2003 May 5;165(19):1989-94. Danish.

MeSH Terms

Conditions

Sepsis

Interventions

Anti-Bacterial AgentsBlood Culture

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesMicrobiological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 16, 2019

First Posted

April 18, 2019

Study Start

October 31, 2018

Primary Completion

February 15, 2019

Study Completion

February 15, 2019

Last Updated

April 18, 2019

Record last verified: 2019-04

Locations