Fluorescent Leukocytes as a Marker of Early Sepsis/Severity

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Strasbourg, France

About this trial

Sepsis is a medical emergency whose prognosis depends on the early identification of patients at risk of septic shock, but the tools available in the Emergency Department remain insufficient. Neutrophils, key players in immunothrombosis, show alterations detectable via cell fluorescence (e.g., NE-SFL), which are strongly correlated with the severity of sepsis and septic DIC. The FLAMES study will evaluate, from the time of admission to the Emergency Department, the relevance of neutrophil fluorescence as an early biomarker of severity, either alone or integrated into an AI model based on the multiparametric data from the SthemA 801, with comparison to the Sysmex XN. It aims to address an unmet clinical need: the immediate stratification of the risk of severe forms of sepsis. Hypothesis: higher initial fluorescence will identify patients at risk of organ failure, septic shock, or DIC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Admission to the ED

Suspected or proven infection defined by the prescription of antibiotic therapy within 24 hours following admission to the ED

Collection of an EDTA blood sample as part of routine care

Disqualifiers

Pregnancy or breastfeeding

Legal protection measure (guardianship, curatorship, judicial protection)

Trial population

Adult patients admitted to the Emergency Department and undergoing routine blood sampling will be prospectively included. The cohort aims to evaluate early biomarkers for the prediction of sepsis or septic shock within 72 hours of admission. No additional procedures or interventions beyond standard care are performed.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

492 Participants
are grouped into 1 trial group
Group A: Emergency Patients

Trial outcomes

Primary outcomes

1

Evaluate the association between neutrophil fluorescence, whether isolated or integrated into an AI model based on CBC results combined with the advanced multiparametric capabilities of the SthemA 801 analyzer

The primary evaluation criterion is the occurrence of sepsis or septic shock within 72 hours following admission to the Emergency Department, defined according to SEPSIS-3 by at least one of the following: * Admission to intensive care, critical care, or continuous care * One or more acute organ failures, defined by a SOFA score ≥ 2 points * Need for vasopressor treatment * Blood lactate \> 2 mmol/L * Death within 72 hours

Time frame
3 days

Secondary outcomes

Other outcomes

Sponsors and contacts

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