Fluorescent Leukocytes as a Marker of Early Sepsis/Severity

N/ANot Yet RecruitingNCT07585942

University Hospital, Strasbourg, France492 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

492

Conditions

Sepsis Disseminated Intravascular Coagulation (DIC)Septic Shock

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 * Patient informed and has not expressed opposition Exclusion Criteria: * Pregnancy or breastfeeding * Legal protection measure (guardianship, curatorship, judicial protection)

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

Time frame: 3 days