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Physician Administered Antibiotics in a Prehospital Setting (PANTIPS)
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Sepsis | Drug: Antibiotics |
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.
| Study Type : | Observational |
| Actual Enrollment : | 117 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | Physician Administered Antibiotics in a Prehospital Mobile Emergency Care Unit |
| Actual Study Start Date : | October 31, 2018 |
| Actual Primary Completion Date : | February 15, 2019 |
| Actual Study Completion Date : | February 15, 2019 |
- Prehospital diagnosis confirmed [ Time Frame: Up to 30 days ]Prehospital tentative diagnosis matches inhospital diagnosis
- Blood culture positive [ Time Frame: First day of admission ]Findings in the blood culture supports the diagnosis sepsis
- Blood culture contamination below 5% [ Time Frame: 6 days ]Findings of bacteria attributed to contamination below 1 in 20 cultures
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | April 16, 2019 | ||||
| First Posted Date | April 18, 2019 | ||||
| Last Update Posted Date | April 18, 2019 | ||||
| Actual Study Start Date | October 31, 2018 | ||||
| Actual Primary Completion Date | February 15, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Prehospital diagnosis confirmed [ Time Frame: Up to 30 days ] Prehospital tentative diagnosis matches inhospital diagnosis
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Physician Administered Antibiotics in a Prehospital Setting | ||||
| Official Title | Physician Administered Antibiotics in a Prehospital Mobile Emergency Care Unit | ||||
| 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. |
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| Detailed 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. |
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| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | All patients treated by the MECU in Odense from November 1st 2013 to October 31st 2018 | ||||
| Condition | Sepsis | ||||
| Intervention | Drug: Antibiotics
Administration of antibiotics
Other Name: Blood culture
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| Study Groups/Cohorts | Not Provided | ||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
117 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | February 15, 2019 | ||||
| Actual Primary Completion Date | February 15, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
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. |
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Denmark | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03919851 | ||||
| Other Study ID Numbers | Prehospital antibiotics | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Soren Mikkelsen, Odense University Hospital | ||||
| Study Sponsor | Odense University Hospital | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Odense University Hospital | ||||
| Verification Date | April 2019 | ||||
