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

NCT06446947 | Recruiting

• 1 other identifier: RCAPHM23_0006
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis Syndrome; Septic Shock; Sepsis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Epigenetic markers comparaison

  18 months

• Differentials in epigenetic marks and associated candidate genes

  18 months

• Epigenetic marks and associated candidate genes identified in PBMC

  18 months

Study Arms (2)

Septic shock

Patients with sepsis admitted to intensive care who developed septic shock.

Other: blood sampling

No septic shock

Patients with sepsis admitted to critical care with a favorable outcome (no septic shock)

Other: blood sampling

Interventions

blood sampling OTHER

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

No septic shock; Septic shock

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Service Anesthésie Réanimation - Hôpital Nord - Assistance Publique Hôpitaux de Marseille

Marseille, Bouches du Rhône, 13015, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

DNA and RNA extracted from patient blood samples will be preserved during the study. At the end of the analysis, the remaining samples will be discarded.

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome; Shock, Septic; Sepsis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Infections

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• François CREMIEUX

  Assistance Publique Hopitaux De Marseille

  STUDY DIRECTOR

Central Study Contacts

Marc LEONE, MD PHD

CONTACT

0491968655; marc.leone@ap-hm.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 6, 2024
• Study Start: March 20, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)