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no participants enrolled
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Septic shock patients | Other | Patients with septic shock will be taken from an additional tube to analyze their immune response |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QuantiFERON Monitor® | Diagnostic Test | The test will be realised to evaluate sepsis induced immunosuppression on patient with septic shock |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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no data sharing plan is planned
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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Monocentric, Open-Label prospective study
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |