An observational study in Sepsis, sponsored by Odense University Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-18.
Sponsored by Odense University Hospital · Observational
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.
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.
1,946 studies on the registry are indexed under Sepsis; 471 are open to participants now.
This study's enrollment of 117 is below the median of 160 across 957 observational studies indexed under Sepsis.
Browse Sepsis studies →Odense University Hospital is the lead sponsor of 477 studies on the registry; 109 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients treated by the MECU in Odense from November 1st 2013 to October 31st 2018
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.
Administration of antibiotics
Also known as: Blood culture
Prehospital diagnosis confirmed
Prehospital tentative diagnosis matches inhospital diagnosis
Time frame: Up to 30 days
Blood culture positive
Findings in the blood culture supports the diagnosis sepsis
Time frame: First day of admission
Blood culture contamination below 5%
Findings of bacteria attributed to contamination below 1 in 20 cultures
Time frame: 6 days
Plan to share: Undecided — Anonymized data may be shared on reasonable request
Ran from Oct 2018 to primary completion in Feb 2019, 3 months.
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This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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