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

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Enrolling

Conditions: Sepsis Syndrome; Septic Shock; Sepsis

Treatments: Other: blood sampling

Study type: Observational

Funder types: Other

Identifiers

NCT06446947

RCAPHM23_0006

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: Male

Ages: 45 to 75 years old

Volunteers: No 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.

Trial design

25 participants in 2 patient groups

Septic shock

Description:

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

Treatment:

Other: blood sampling

No septic shock

Description:

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

Treatment:

Other: blood sampling