Identification of Markers of Poor Clinical Prognosis in Sepsis by Epigenetic Analysis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: blood sampling.
- Who it may be relevant to
- Registry conditions: Sepsis Syndrome, Septic Shock, Sepsis. Basic parameters: 45 years — 75 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Identification de Marqueurs de Mauvais Pronostic Clinique du Sepsis Par Analyse épigénétique.
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.
Interventions
- Other blood sampling
Blood sampling (6ml) on admission and a second on discharge from intensive care.
Primary outcome measures
- Identify prognostic markers for the progression of sepsis to septic shock [Time frame: 18 months]
Secondary outcome measures (3)
- Epigenetic markers comparaison [Time frame: 18 months]
- Differentials in epigenetic marks and associated candidate genes [Time frame: 18 months]
- Epigenetic marks and associated candidate genes identified in PBMC [Time frame: 18 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
France · 1 center
- Service Anesthésie Réanimation - Hôpital Nord - Assistance Publique Hôpitaux de Marseille — Marseille
Identifiers
NCT: NCT06446947 · RCAPHM23_0006