Sepsis, Sepsis Syndrome, Septic Shock
Conditions
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.
Interventions
OTHERblood sampling
Blood sampling (6ml) on admission and a second on discharge from intensive care.
Sponsors
Assistance Publique Hopitaux De Marseille
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
45 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identify prognostic markers for the progression of sepsis to septic shock | 18 months | Compare targeted markers between subjects with sepsis progressing to septic shock versus subjects with sepsis not progressing to septic shock. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Epigenetic markers comparaison | 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. |
| Differentials in epigenetic marks and associated candidate genes | 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 |
| Epigenetic marks and associated candidate genes identified in PBMC | 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. |
Countries
France
Contacts
CONTACTMarc LEONE, MD PHD
STUDY_DIRECTORFrançois CREMIEUX
Assistance Publique Hopitaux De Marseille
Outcome results
None listed