Biomarkers for the Early Identification of Sepsis in the Emergency Department

Completed

• Conditions: Sepsis

• Registration Number: NCT02707718
• Lead Sponsor: Pitié-Salpêtrière Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-02-26
• Study Start: 2016-03-01
• Study First Submitted QC: 2016-03-08
• Study First Posted: 2016-03-14
• Primary Completion: 2018-03-03
• Study Completion: 2018-03-03
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-13
• Last Update Posted: 2018-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
sepsis diagnosis	30-day after inclusion	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

Secondary Outcome Measures

Name	Time	Method
severe outcome defined by: severe sepsis and/or septic shock and/or ICU admission and/or death in the 30-day follow-up	30-day after inclusion	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.

Trial Locations

Locations (2)

Hôpital Pitié Salpêtrière; 🇫🇷 Paris, France

Institut Pasteur; 🇫🇷 Paris, France