Identification of Markers of Poor Clinical Prognosis in Sepsis by Epigenetic Analysis (EPISEPSIS)

Identification de Marqueurs de Mauvais Pronostic Clinique du Sepsis Par Analyse épigénétique.

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.

Study Overview

• Status: Recruiting
• Conditions: Sepsis; Septic Shock; Sepsis Syndrome
• Intervention / Treatment: Other: blood sampling

• Study Type: Observational
• Enrollment (Estimated): 25

Contacts and Locations

• Study Contact: Name: Marc LEONE, MD PHD; Phone Number: 0491968655; Email: marc.leone@ap-hm.fr

Study Locations

• France
  • Bouches du Rhône
    • Marseille, Bouches du Rhône, France, 13015
      • Recruiting
      • Service Anesthésie Réanimation - Hôpital Nord - Assistance Publique Hôpitaux de Marseille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Male patients admitted to critical care for sepsis after thoracic or chest surgery.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Septic shock; Patients with sepsis admitted to intensive care who developed septic shock.	Other: blood sampling; Blood sampling (6ml) on admission and a second on discharge from intensive care.
No septic shock; Patients with sepsis admitted to critical care with a favorable outcome (no septic shock)	Other: blood sampling; Blood sampling (6ml) on admission and a second on discharge from intensive care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify prognostic markers for the progression of sepsis to septic shock	Compare targeted markers between subjects with sepsis progressing to septic shock versus subjects with sepsis not progressing to septic shock.	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epigenetic markers comparaison	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.	18 months
Differentials in epigenetic marks and associated candidate genes	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	18 months
Epigenetic marks and associated candidate genes identified in PBMC	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.	18 months

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Study Director: François CREMIEUX, Assistance Publique Hopitaux de Marseille

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: May 29, 2024
• First Submitted That Met QC Criteria: June 5, 2024
• First Posted (Actual): June 6, 2024

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Shock; Pathological Conditions, Signs and Symptoms; Sepsis; Shock, Septic; Systemic Inflammatory Response Syndrome; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: RCAPHM23_0006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No