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

Assistance Publique Hopitaux De Marseille25 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Sepsis Syndrome Septic Shock Sepsis

Interventions

blood samplingOTHER

Eligibility

Sex: MALEMin age: 45 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 18 months

Secondary Outcomes

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.

Time frame: 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

Time frame: 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.

Time frame: 18 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts