Kinetics of INF-γ Production in Intensive Care Patients

NCT06549374 | Recruiting

• 1 other identifier: APHP240860
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Intensive Care

Keywords

INF-γ; Inflammation; immunostimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• ICU discharge Vital status

  at ICU discharge, and at the latest Day 28

• Incidence of nosocomial infections

  From ICU-admission to ICU-discharge, and at the latest Day 28

• Incidence of viral reactivations for CMV and HSV

  From ICU-admission to ICU-discharge, and at the latest Day 28

• Length of mechanical ventilation

  From ICU-admission to ICU-discharge, and at the latest Day 28

• Presence of septic shock

  From ICU-admission to ICU-discharge, and at the latest Day 28

Study Arms (1)

Adults in Intensive care

Patient included will be adult patients admitted to intensive care after severe trauma, high-risk surgery, or presenting with acute respiratory distress

Other: blood sampling

Interventions

blood sampling OTHER

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.

Adults in Intensive care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient included will be adult patients admitted to intensive care after severe trauma, high-risk surgery, or presenting with acute respiratory distress

You may qualify if:

• Aged 18 years or older

You may not qualify if:

• Expressed opposition from the patient, a relative (if applicable), or their legal representative (guardian, curator)
• Pregnant woman

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (7)

Reanimation department, Annecy Genevois hospital

Annecy, 74370, France

NOT YET RECRUITING

Reanimation department, Clermont-Ferrand Hospital

Clermont-Ferrand, 63000, France

NOT YET RECRUITING

Reanimation department, Lyon hospital

Lyon, 69003, France

NOT YET RECRUITING

Réanimation cardio-chirurgicale - Pitié-Salpêtrière hospital

Paris, Île-de-France Region, 75013, France

RECRUITING

Réanimation chirurgicale Gaston Cordier - Pitié-Salpêtrière hospital

Paris, Île-de-France Region, 75013, France

RECRUITING

Réanimation chirurgicale Husson Mourrier - Pitié-Salpêtrière hospital

Paris, Île-de-France Region, 75013, France

NOT YET RECRUITING

Réanimation neuro-chirurgicale - Pitié-Salpêtrière hospital

Paris, Île-de-France Region, 75013, France

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Inflammation

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Jean-michel Constantin, MD, PhD

CONTACT

33142161936; jean-michel.constantin@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 12, 2024
• Study Start: April 24, 2025
• Primary Completion: April 24, 2026
• Study Completion (Estimated): May 24, 2026
• Last Updated: December 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

FR (7)