Understanding immune response in intensive care patients

Kinetics of INF-γ Production in Intensive Care Patients-Monitoring of INF-γ in Intensive Care

This study is trying to see how the immune system responds in intensive care patients after serious injuries or surgeries to find the best ways to boost their immune defense and improve their recovery.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (other)
• Locations: 7 sites (Annecy and 6 other locations)
• Trial ID: NCT06549374 on ClinicalTrials.gov

What this trial studies

This observational study investigates the production of interferon gamma (IFN-γ) in patients admitted to intensive care following severe trauma, high-risk surgery, or acute respiratory distress. It aims to identify the immunosuppressive phase in these patients through blood sampling and biomarkers, particularly focusing on the expression of Human Leukocyte Antigen (HLA-DR) on monocytes. The study seeks to determine the optimal timing and patient selection for potential immunostimulation therapies to improve immune defense and reduce complications. By understanding these dynamics, the research hopes to enhance patient outcomes in critical care settings.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 years or older who are admitted to intensive care after severe trauma, acute respiratory distress, or major surgeries requiring postoperative intensive care.

Not a fit: Patients who may not benefit from this study include those who are pregnant, have expressed opposition to participation, or have a hemoglobin level below 7g/dl at inclusion.

Why it matters

Potential benefit: If successful, this study could lead to improved identification and treatment strategies for critically ill patients, potentially reducing infection rates and mortality.

How similar studies have performed: While previous studies on IFN-γ have shown mixed results, this approach of using biomarkers to guide treatment timing and patient selection is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Aged 18 years or older
* Patients admitted to intensive care after severe trauma, or presenting with acute respiratory distress, or undergoing cardiac, vascular, or digestive surgery with planned postoperative intensive care. Exclusion Criteria

Exclusion Criteria:

* Expressed opposition from the patient, a relative (if applicable), or their legal representative (guardian, curator)
* Pregnant woman
* Hemoglobin less than 7g/dl at inclusion

Where this trial is running

Annecy and 6 other locations

• Reanimation department, Annecy Genevois hospital — Annecy, France (NOT_YET_RECRUITING)
• Reanimation department, Clermont-Ferrand Hospital — Clermont-Ferrand, France (NOT_YET_RECRUITING)
• Reanimation department, Lyon hospital — Lyon, France (NOT_YET_RECRUITING)
• Réanimation cardio-chirurgicale - Pitié-Salpêtrière hospital — Paris, Île-de-France Region, France (RECRUITING)
• Réanimation chirurgicale Gaston Cordier - Pitié-Salpêtrière hospital — Paris, Île-de-France Region, France (RECRUITING)
• Réanimation chirurgicale Husson Mourrier - Pitié-Salpêtrière hospital — Paris, Île-de-France Region, France (NOT_YET_RECRUITING)
• Réanimation neuro-chirurgicale - Pitié-Salpêtrière hospital — Paris, Île-de-France Region, France (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Jean-michel Constantin, MD, PhD

Conditions: Intensive Care, INF-γ, Inflammation, immunostimulation