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

Sepsis Clinical Trial

— EPISEPSIS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06446947
• Other study ID #: RCAPHM23_0006
• Status: Not yet recruiting
• Start date: July 1, 2024
• Est. completion date: January 11, 2026

Study information

• Verified date: May 2024
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Marc LEONE, MD PHD
• Phone: 0491968655
• Email: marc.leone[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: January 11, 2026
• Est. primary completion date: January 11, 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sepsis
• Sepsis Syndrome
• Septic Shock
• Systemic Inflammatory Response Syndrome
• Toxemia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	18 months
Secondary	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.	18 months
Secondary	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	18 months
Secondary	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.	18 months