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

NCT ID: NCT06446947

Last Updated: 2025-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-20

Study Completion Date

2026-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Sepsis Syndrome Septic Shock Sepsis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Septic shock

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

blood sampling

Intervention Type OTHER

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

No septic shock

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

blood sampling

Intervention Type OTHER

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

Interventions

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blood sampling

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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François CREMIEUX

Role: STUDY_DIRECTOR

Assistance Publique Hopitaux De Marseille

Locations

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Service Anesthésie Réanimation - Hôpital Nord - Assistance Publique Hôpitaux de Marseille

Marseille, Bouches du Rhône, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Marc LEONE, MD PHD

Role: CONTACT

0491968655

Other Identifiers

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RCAPHM23_0006

Identifier Type: -

Identifier Source: org_study_id

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