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NCT Number: NCT06446947

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

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.

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Key information

Conditions

Sepsis Syndrome Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

45 year–75 year

Sex eligibility

Male

Study type

Observational

Primary location

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

Marseille, Bouches du Rhône, 13015, France

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood sampling

Other

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

Primary outcomes

  1. Identify prognostic markers for the progression of sepsis to septic shock

    Time frame: 18 months

    Compare targeted markers between subjects with sepsis progressing to septic shock versus subjects with sepsis not progressing to septic shock.

Secondary outcomes

  1. Epigenetic markers comparaison

    Time frame: 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.

  2. Differentials in epigenetic marks and associated candidate genes

    Time frame: 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

  3. Epigenetic marks and associated candidate genes identified in PBMC

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marc LEONE, MD PHD

CONTACT

[email protected]

0491968655

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study title

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

Acronym: EPISEPSIS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 6, 2024
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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