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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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
Sponsors and contacts
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