NCT07585942|Not Yet Recruiting
Fluorescent Leukocytes as a Marker of Early Sepsis/Severity
FLAMES
NEUTROPHIL FLUORESCENCE AS AN EARLY BIOMARKER OF SEPSIS SEVERITY IN THE EMERGENCY DEPARTMENT
Loading search results
FLAMES
NEUTROPHIL FLUORESCENCE AS AN EARLY BIOMARKER OF SEPSIS SEVERITY IN THE EMERGENCY DEPARTMENT
Sponsor study identifier
Secondary identifiers
OTHER · ETHICS COMMITTEE of the Faculties of Medicine, Dentistry, Pharmacy, Nursing Schools, Physiotherapy, Midwifery, and Hosp
observational
492
1 country
1
Study Start
May 12, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 12, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 12, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 12, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 6, 2026
Actual (reported)May 12, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 14, 2026
Actual (reported)November 12, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 12, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
3 days
Prospective multicenter observational cohort study evaluating the prognostic value of neutrophil fluorescence parameters measured at emergency department admission using a novel hematology analyzer. Data are collected from routine blood samples and used to develop an artificial intelligence model without additional intervention.
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.
The University Hospitals of Strasbourg, Intensive Care Medicine Department - New Civil Hospital
Strasbourg, 67098, France
First Submitted
May 6, 2026
First Posted
May 14, 2026
Study Start
May 12, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 12, 2027
EstimatedCortisol Levels and Mortality in Septic Shock ICU Patients
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 12, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 14, 2026
Record last verified: 2026-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: