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

Recruiting

• Conditions: Sepsis Syndrome; Septic Shock; Sepsis
• Interventions: Other: blood sampling

• Registration Number: NCT06446947
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-29
• Study First Submitted QC: 2024-06-05
• Study First Posted: 2024-06-06
• Status Verified: 2025-01
• Study Start: 2025-03-20
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-03
• Primary Completion: 2026-09-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 25

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Septic shock	blood sampling	Patients with sepsis admitted to intensive care who developed septic shock.
No septic shock	blood sampling	Patients with sepsis admitted to critical care with a favorable outcome (no septic shock)

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Epigenetic marks and associated candidate genes identified in PBMC	18 months	In both groups, compare the epigenetic marks and associated candidate genes identified in PBMC during sepsis with those identified in PBMC collected at the time of septic shock or discharge from critical care.
Epigenetic markers comparaison	18 months	Epigenetic markers and associated candidate genes identified in PBMC at the time of sepsis between the group of subjects progressing to septic shock and the group of subjects not progressing to septic shock.
Differentials in epigenetic marks and associated candidate genes	18 months	Compare differentials in epigenetic marks and associated candidate genes (sepsis, second sampling) between the group of subjects progressing to septic shock and the group of subjects not progressing to septic shock

Trial Locations

Locations (1)

Service Anesthésie Réanimation - Hôpital Nord - Assistance Publique Hôpitaux de Marseille; 🇫🇷 Marseille, Bouches du Rhône, France