Biomarkers for the Early Identification of Sepsis in the Emergency Department

Study Overview
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Brief Summary
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Monocentric prospective study on consecutive patients attending the emergency department and suspected to have sepsis. Blood sampling for the measurement of a panel of biomarkers of interest in sepsis.

Detailed Description
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The management of patients admitted to the emergency department (ED) requires investigative biological parameters that help clinicians to make the right diagnosis. Sepsis concerns patients with infection associated with a systemic inflammatory response. While this inflammatory profile is observed in many clinical situations in the ED, the challenge is to characterize in these patients suspected of sepsis those who have a real infection. Currently, no individual biomarker of sepsis is sufficiently discriminant. The objective of this study is to measure in patients suspected of sepsis in the emergency department, a combination of biomarkers (covering several distinct pathophysiological pathways) that could provide high specificity and sensitivity for the diagnostic and prognostic. The originality of this study is that compared with patients admitted to intensive care units, patients investigated for suspected sepsis in the ED are seen earlier in their medical history and usually before any therapeutic intervention (intravenous fluids, antibiotics, catecholamines) interfering with several biomarkers of interest.

Official Title
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Early Biomarkers of Sepsis Identification in the Emergency Department

Conditions
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Sepsis

Intervention / Treatment
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* Biological: blood sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient attending the ED and suspected to have sepsis by the emergency physician after clinical exam Exclusion Criteria: patient minor under 18-year pregnancy anticipated no follow-up possible (homeless...) Refusal to participate patient under curators, prisoner

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: blood sampling|during the usual blood sampling performed in the ED in patients suspected of sepsis, two additional tubes will be sampled for a panel of biomarkers measurement|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sepsis diagnosis | Among the patients included in the study with a sepsis suspicion, the primary outcome measure will be a final diagnosis of sepsis adjudicated on the medical file and 30-day follow-up, by an expert panel blind for the biomarkers studied | 30-day after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| severe outcome defined by: severe sepsis and/or septic shock and/or ICU admission and/or death in the 30-day follow-up | Among the patients included in the study with a sepsis suspicion, a diagnosis of severe sepsis and/or septic shock will be adjudicated on the medical file and 30-day follow-up by an expert panel blind for the biomarkers studied. ICu admission and death will be recorded by the medical file and 30-day phone interview. | 30-day after inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sepsis, biomarker, prognostic, emergency department, diagnosis