Identification of Markers of Poor Clinical Prognosis in Sepsis by Epigenetic Analysis

NCT06446947 · tracked via the Priya Life Science France tracker

Sponsor

Assistance Publique Hopitaux De Marseille

Phase

Observational

Started

2025-03-20

Last updated

2026-02-12

Condition(s) studied

Sepsis SyndromeSeptic ShockSepsis

Investigational drug(s) / intervention(s)

blood sampling

blood sampling: Blood sampling (6ml) on admission and a second on discharge from intensive care.

Study summary

Sepsis is a multifactorial syndrome characterized by a dynamic course and a clinical outcome dependent on several factors, and responsible for one in five deaths worldwide. The aim of this trial is to identify new prognostic markers for the progression of sepsis to septic shock, by comparing epigenetic markers between patients who have or have not developed severe forms of sepsis.

The main objective of this preliminary study is to identify prognostic markers for the progression of sepsis to septic shock, i.e. to compare targeted markers between subjects with sepsis who progress to septic shock versus subjects with sepsis who do not progress to septic shock.

Eligibility

Sex

MALE

Min age

45 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: * Male patients, * Patients between 45 and 75 years of age, * Patients undergoing major esophageal or digestive carcinological surgery, * Patients with post-operative gram-negative bacterial sepsis (proven or suspected in the context of organ failure). Exclusion Criteria: * patients under 45 and aged 76 and over, * female patients, * non-carcinological or minor surgery, * non-esophageal or non-digestive surgery, * Gram-positive bacterial or fungal infections in the absence of associated BGN, * patients with hematological cancer, * immunocompromised patients, * septic surgery (surgical site infection), * patients expressing opposition to data collection and analysis (clinical and/or biological) within the regulatory framework of the study, * patients under guardianship or curatorship, * patients not affiliated to a social security system or equivalent in France, * patients deprived of their liberty.

Primary outcome measure(s)

Identify prognostic markers for the progression of sepsis to septic shock — 18 months
Compare targeted markers between subjects with sepsis progressing to septic shock versus subjects with sepsis not progressing to septic shock.

Trial sites (1)

Facility	City	Region	Status
Service Anesthésie Réanimation - Hôpital Nord - Assistance Publique Hôpitaux de Marseille	Marseille	Bouches du Rhône	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06446947 on ClinicalTrials.gov ↗ ← All trials in France