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

Septic Shock Clinical Trial

— MONITOR SEPSIS  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04320394
• Other study ID #: 19-AOI-08
• Status: Withdrawn
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: July 1, 2022

Study information

• Verified date: March 2020
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Diagnostic Test:
• QuantiFERON Monitor®
The test will be realised to evaluate sepsis induced immunosuppression on patient with septic shock

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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-?, the QuantiFERON Monitor®	Use of an objective and functional immunological test measuring the production of IFN-?, the QuantiFERON Monitor®	24 months
Secondary	obtaining a threshold value of IFN - ? in the plasma of patients to define an immunosuppression threshold and then to predict the occurrence of secondary infectious complications.	the value of IFN - ? (UI/mL) in the plasma will be mesured after stimulation of the immune cells,	24 months