Septic Shock
Conditions
Brief summary
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
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.
Interventions
DIAGNOSTIC_TESTQuantiFERON Monitor®
The test will be realised to evaluate sepsis induced immunosuppression on patient with septic shock
Sponsors
Centre Hospitalier Universitaire de Nice
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Monocentric, Open-Label prospective study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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® | 24 months | Use of an objective and functional immunological test measuring the production of IFN-γ, the QuantiFERON Monitor® |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 24 months | the value of IFN - γ (UI/mL) in the plasma will be mesured after stimulation of the immune cells, |
Outcome results
None listed