Physician Administered Antibiotics in a Prehospital Setting (PANTIPS)
Physician Administered Antibiotics in a Prehospital Mobile Emergency Care Unit
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.
Aperçu de l'étude
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
-
Odense, Danemark, 5000
- Mobile Emergency Care Unit in Odense
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Prehospital diagnosis confirmed
Délai: Up to 30 days
|
Prehospital tentative diagnosis matches inhospital diagnosis
|
Up to 30 days
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Blood culture positive
Délai: First day of admission
|
Findings in the blood culture supports the diagnosis sepsis
|
First day of admission
|
|
Blood culture contamination below 5%
Délai: 6 days
|
Findings of bacteria attributed to contamination below 1 in 20 cultures
|
6 days
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Prehospital antibiotics
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Antibiotics
-
Tan Tock Seng HospitalNational Healthcare Group Polyclinics; Temasek PolytechnicComplétéRésistance antimicrobienneSingapour
-
Kenneth HargreavesRetiréRégénération de la pulpe dentaireÉtats-Unis