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Kinetics of INF-γ Production in Intensive Care Patients
Sponsor: Assistance Publique - Hôpitaux de Paris
Summary
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.
Official title: Kinetics of INF-γ Production in Intensive Care Patients-Monitoring of INF-γ in Intensive Care
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
200
Start Date
2025-04-24
Completion Date
2026-05-24
Last Updated
2025-12-11
Healthy Volunteers
No
Conditions
Interventions
blood sampling
After informing eligible patients (or their trusted support person, relative/guardian/curator where applicable) and in the absence of any opposition, they are included in the research. Blood samples from an arterial catheter already in place will be taken every day from D1 to D7, then every 72 hours until discharge from intensive care, or until D28. For each of these samples, a maximum volume of 4 ml will be collected in a heparinized tube. Samples will not be taken if the hemoglobin level is below 7g/dl. For patients undergoing controlled surgery, the D1 sample will be taken as soon as possible after induction of anaesthesia. Patients will be monitored until discharge from intensive care, or until D28 at the latest. Apart from the blood samples included in this study, all other examinations will be carried out as part of routine management. Data will be collected exclusively from medical records.
Locations (7)
Reanimation department, Annecy Genevois hospital
Annecy, France
Reanimation department, Clermont-Ferrand Hospital
Clermont-Ferrand, France
Reanimation department, Lyon hospital
Lyon, France
Réanimation cardio-chirurgicale - Pitié-Salpêtrière hospital
Paris, Île-de-France Region, France
Réanimation chirurgicale Gaston Cordier - Pitié-Salpêtrière hospital
Paris, Île-de-France Region, France
Réanimation chirurgicale Husson Mourrier - Pitié-Salpêtrière hospital
Paris, Île-de-France Region, France
Réanimation neuro-chirurgicale - Pitié-Salpêtrière hospital
Paris, Île-de-France Region, France