Evaluation of Sepsis-induced Immunosuppression Base on QuantiFERON Monitor® in Septic Shock

Study Overview
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Brief Summary
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QuantiFERON Monitor® is an immunological test evaluating the nonspecific cellular response by measuring interferon gamma (IFNγ) secretions after T-cell and natural killer lymphocyte stimulation. This study aims at evaluating sepsis-induced immunosuppression base on QuantiFERON Monitor® in patients presenting to the intensive care unit for septic shock. The sponsor expects to identify sepsis-induced immunodeficiency in patients through a better understanding of cellular and adaptive immune responses.

Detailed Description
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A sepsis-induced immunosuppression phase has recently been characterized and has been associated with worse outcomes as well as increased healthcare costs. Furthermore, a marked suppression of the immune response has been partially described in patients hospitalized in the intensive care setting but its monitoring is not available in daily practice. QuantiFERON Monitor® is an immunological test evaluating the nonspecific cellular response by measuring interferon gamma (IFNγ) secretions after T-cell and natural killer lymphocyte stimulation. Several studies have shown the pertinence of this test, especially in patients with kidney failure requiring renal replacement therapy. Patients with lower IFNγ levels were also found to be at higher risk of infection. This study aims at evaluating sepsis-induced immunosuppression base on QuantiFERON Monitor® in patients presenting to the intensive care unit for septic shock. The sponsor expects to identify sepsis-induced immunodeficiency in patients through a better understanding of cellular and adaptive immune responses. This should ultimately lead to determining thresholds for sepsis-related complications and identifying patients most at risk of sepsis-induced immuno-depression.

Official Title
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Evaluation of Sepsis-induced Immunosuppression Base on QuantiFERON Monitor® in Patients Presenting to the Intensive Care Unit for Septic Shock

Conditions
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Septic Shock

Intervention / Treatment
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* Diagnostic Test: QuantiFERON Monitor®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient hospitalized in intensive care and intensive care at Nice University Hospital and presenting with septic shock (defined by the presence of sepsis, the need for a vasopressor to maintain a MAP> 65mmHg and hyperlactatemia> 2mmol / l) Free and express informed consent signed by the patient or the confidential counselor in case of impossibility (deferred consent of the patient as soon as his condition allows it) Age> 18 years old Affiliated to a social security scheme Exclusion Criteria: Pregnant woman Patient under the age of 18 Patient under guardianship or curatorship or placed in detention Patient with congenital or previously acquired immune deficiency Patient on prior immunosuppressive treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Monocentric, Open-Label prospective study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Septic shock patients<br>Patients with septic shock will be taken from an additional tube to analyze their immune response | Diagnostic Test: QuantiFERON Monitor®<br>* The test will be realised to evaluate sepsis induced immunosuppression on patient with septic shock<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| identification of patients with sepsis-induced immunosuppression in a population of patients with septic shock, by an objective and functional immunological test measuring the production of IFN-γ, the QuantiFERON Monitor® | Use of an objective and functional immunological test measuring the production of IFN-γ, the QuantiFERON Monitor® | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| obtaining a threshold value of IFN - γ in the plasma of patients to define an immunosuppression threshold and then to predict the occurrence of secondary infectious complications. | the value of IFN - γ (UI/mL) in the plasma will be mesured after stimulation of the immune cells, | 24 months |