Identifying Prognostic Markers in Sepsis
Identification de Marqueurs de Mauvais Pronostic Clinique du Sepsis Par Analyse épigénétique.
This study is trying to find new signs in the blood that can help predict which patients with severe sepsis might develop septic shock after major surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 45 Years to 75 Years |
| Sex | Male |
| Sponsor | Assistance Publique Hopitaux De Marseille Academic / other |
| Locations | 1 site (Marseille, Bouches du Rhône) |
| Trial ID | NCT06446947 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify new prognostic markers for the progression of sepsis to septic shock by comparing epigenetic markers in patients who develop severe forms of sepsis against those who do not. The study involves blood sampling from male patients aged 45 to 75 who are undergoing major esophageal or digestive surgery and have post-operative gram-negative bacterial sepsis. By analyzing these markers, researchers hope to better understand the factors that influence the clinical outcomes of sepsis.
Who should consider this trial
Good fit: Ideal candidates for this study are male patients aged 45 to 75 who are undergoing major esophageal or digestive surgery and have post-operative gram-negative bacterial sepsis.
Not a fit: Patients outside the age range of 45 to 75, female patients, or those with non-carcinological surgeries will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prognostic tools for predicting the progression of sepsis, potentially enhancing patient management and outcomes.
How similar studies have performed: While this approach is focused on epigenetic markers in sepsis, similar studies have shown promise in identifying prognostic factors in other critical conditions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Marseille, Bouches du Rhône
- Service Anesthésie Réanimation - Hôpital Nord - Assistance Publique Hôpitaux de Marseille — Marseille, Bouches du Rhône, France (Recruiting)
Study contacts
- Study coordinator: Marc LEONE, MD PHD
- Email: marc.leone@ap-hm.fr
- Phone: 0491968655
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.