Kinetics of INF-γ Production in Intensive Care Patients
NCT Number: NCT06549374
Acronym: IGREY
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Intensive Care
Interventions: OTHER: blood sampling
Sponsor: Assistance Publique - Hôpitaux de Paris
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2026-11-01

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.

Primary Outcome Measures: INF-γ production in patients admitted to intensive care after severe trauma, high-risk surgery, or acute respiratory distress, The measurement of INF-γ production will be conducted using a fully automated Interferon Gamma Realease Assay (IGRA) test., Daily value from day 1 to day 7, then every 72 hours until discharge from intensive care (assessed up to day 28).
Secondary Outcome Measures: ICU discharge Vital status, Vital status at discharge from ICU, at ICU discharge, and at the latest Day 28|Incidence of nosocomial infections, Incidence of nosocomial infections occurring in the ICU : number, type, and duration of antibiotic therapy, From ICU-admission to ICU-discharge, and at the latest Day 28|Incidence of viral reactivations for CMV and HSV, Incidence of viral reactivations as detected by PCR for CMV (Cytomegalovirus) and HSV (Herpes Simplex Virus) in the ICU, From ICU-admission to ICU-discharge, and at the latest Day 28|Length of mechanical ventilation, Duration of mechanical ventilation in ICU, From ICU-admission to ICU-discharge, and at the latest Day 28|Presence of septic shock, Presence of septic shock in the ICU, From ICU-admission to ICU-discharge, and at the latest Day 28|Renal impairment, Renal impairment defined by a Kidney Disease Improving Global Outcomes (KDIGO) score \> 1.

Scale of 1 to 3, with 3 corresponding to severe acute kidney damage., From ICU-admission to ICU-discharge, and at the latest Day 28|mHLA-DR expression, mHLA-DR expression by flow cytometry, Daily value from day 1 to day 7, then every 72 hours until discharge from intensive care (assessed up to day 28).|Length of ICU stay, Length of stay in intensive care, at ICU discharge, and at the latest day 28