Physician Administered Antibiotics in a Prehospital Setting

Sepsis Clinical Trial

— PANTIPS  

Official title:

Physician Administered Antibiotics in a Prehospital Mobile Emergency Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03919851
• Other study ID #: Prehospital antibiotics
• Status: Completed
• Start date: October 31, 2018
• Est. completion date: February 15, 2019

Study information

• Verified date: April 2019
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

In Denmark, the Emergency Medical System (EMS) consists of not only ambulances operated by paramedics and emergency technicians (EMTs) but also of Mobile Emergency Care Unit (MECU) staffed with an emergency physician with specialist training in anesthesiology and a paramedic. Only the physician on the MECU can administer prehospital antibiotics in Denmark; this emphasizes the importance of the first responding emergency units' capability in detecting and realizing the need for antibiotics in a patient so that the MECU can be requested and treatment initiated quickly.

Determining the administration of antibiotics is done at the anesthesiologists' discretion.

The purpose of administering antibiotics prehospitally is to reduce the time gap between suspicion of sepsis arises and the administration of antibiotics.

The purpose of this retrospective study is to conduct a quality control of the obtaining of blood cultures and of the administration of antibiotics in the prehospital setting serviced by the MECU in Odense in the Region of Southern Denmark in a time interval of 5 years (November 2013- October 2018).

The primary purpose is to associate the prehospital tentative diagnosis (assigned by the MECU) with the final diagnosis (ICD10 from hospital charts) including: 1: An indication for antibiotic therapy and 2: An assessment of the feasibility and potential benefit of the blood cultures obtained. 3: A description of the bacteria found in the blood cultures.

The association between initial prehospital diagnosis and final the diagnosis will be compared.

Secondly the patients seen by the MECU will be characterized regarding diagnosis (ICD10-classification), age, sex, medication, and the first set of vital parameters (Heart rate, Blood pressure, Respratory rate, Oxygen saturation, Glasgow Coma Score, Temperature).

Hypothesis The indication for giving prehospital antibiotics is supported by the prehospital blood culture and by additional findings reproduced inhospitally.

The prehospital tentative diagnosis is confirmed in-hospitally. Prehospital blood sampling is associated with an acceptably low range of contamination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: February 15, 2019
• Est. primary completion date: February 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion: Criteria: Antibiotics administrated by prehospital physician

Exclusion: Criteria: Age below 18 years. No prehospital administration of antibiotics. Patients without inhospital medical records or patients released at the prehospital scene following treatment.

Related Conditions & MeSH terms

• Sepsis

Intervention

Drug:
• Antibiotics
Administration of antibiotics

Locations

Country	Name	City	State
Denmark	Mobile Emergency Care Unit in Odense	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (9)

Andersson H, Axelsson C, Larsson A, Bremer A, Gellerstedt M, Bång A, Herlitz J, Ljungström 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 — View Citation

Bodilsen J, Dalager-Pedersen M, Schønheyder 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. — View Citation

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. — View Citation

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. — View Citation

Justesen US, Larsen BW, Eshøj O, Søgaard P. [Blood cultures--indication and antibiotic therapy]. Ugeskr Laeger. 2003 May 5;165(19):1989-94. Danish. — View Citation

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 anti — View Citation

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). pii: V09170685. Review. Danish. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prehospital diagnosis confirmed	Prehospital tentative diagnosis matches inhospital diagnosis	Up to 30 days
Secondary	Blood culture positive	Findings in the blood culture supports the diagnosis sepsis	First day of admission
Secondary	Blood culture contamination below 5%	Findings of bacteria attributed to contamination below 1 in 20 cultures	6 days