Kinetics of INF-γ Production in Intensive Care Patients

Recruiting now

Conditions studied: Intensive Care

In brief

Most patients admitted to intensive care after severe trauma, high-risk surgery, or acute respiratory distress are frequently characterized by significant initial inflammation accompanied by a compensatory anti-inflammatory response, which can lead to profound post-aggressive immunosuppression. This immunosuppression is associated with an increased risk of nosocomial infections, viral reactivations, prolonged ICU stays, and ultimately, increased mortality. Consequently, immunostimulation with agents such as interferon gamma (IFN-γ) has been proposed as a means to restore immune defense in the most severe patients. However, in a recent study conducted on mechanically ventilated patients with acute organ failure, treatment with interferon gamma-1b compared to placebo did not significantly reduce the incidence of nosocomial pneumonia or 28-day mortality and was even associated with an increase in severe side effects, leading to the premature termination of the trial. These results, along with previous studies, suggest that for IFN-γ to be effective, it must be targeted at patients who have reached the immunosuppressive phase. In the absence of evident clinical signs, the use of biomarkers could guide clinicians in identifying the appropriate patients and the optimal timing for this therapy. In a recent monocentric study, they evaluated a new automated IFN-γ assay on a cohort of 22 septic patients to monitor T lymphocyte functionality independently of antigen. As expected, the results showed a marked decrease in IFN-γ release, which correlated with altered classical cellular parameters (CD8+ T cells, mHLA-DR). Since the test is performed using whole blood, requires no technician intervention, and provides results within four hours, this project propose to characterize the evolution of the immune status of a large cohort of ICU patients, including those with severe trauma, high-risk surgery, or acute respiratory distress syndrome.

Key facts

Study ID

NCT06549374

Run by

Assistance Publique - Hôpitaux de Paris

People needed

200

Starts

2025-04-24

Expected to finish

2026-10-24

Last updated by the study team

2026-05-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

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

Full record on ClinicalTrials.gov

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