Skip to main content
Clinical Trials/NCT02707718
NCT02707718
Completed
Not Applicable

Early Biomarkers of Sepsis Identification in the Emergency Department

Pitié-Salpêtrière Hospital2 sites in 1 country320 target enrollmentMarch 1, 2016
ConditionsSepsis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sepsis
Sponsor
Pitié-Salpêtrière Hospital
Enrollment
320
Locations
2
Primary Endpoint
sepsis diagnosis
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2016
End Date
March 3, 2018
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Pitié-Salpêtrière Hospital
Responsible Party
Principal Investigator
Principal Investigator

Hausfater Pierre

Principal investigator

Pitié-Salpêtrière Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

sepsis diagnosis

Time Frame: 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 Outcomes

  • 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)

Study Sites (2)

Loading locations...

Similar Trials