Health TrialsbyHealthPanel

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

ConditionsSepsis SyndromeSeptic ShockSepsis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age45-75
SponsorAssistance Publique Hopitaux De Marseille

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

patients under 45 and aged 76 and over,

female patients,

non-carcinological or minor surgery,

non-esophageal or non-digestive surgery,

Trial population

Male patients admitted to critical care for sepsis after thoracic or chest surgery.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • blood sampling

    Other intervention

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

Treatment groups

25 Participants
are divided into 2 treatment groups
Group A: Septic shock1 intervention
Group B: No septic shock1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique Hopitaux De Marseille

Lead sponsor

Source ClinicalTrials.gov
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