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

NCT04320394 | Withdrawn

• 1 other identifier: 19-AOI-08
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Septic shock patients

OTHER

Patients with septic shock will be taken from an additional tube to analyze their immune response

Diagnostic Test: QuantiFERON Monitor®

Interventions

QuantiFERON Monitor® DIAGNOSTIC_TEST

The test will be realised to evaluate sepsis induced immunosuppression on patient with septic shock

Septic shock patients

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Monocentric, Open-Label prospective study

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: March 25, 2020
• Study Start: July 1, 2020
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: July 27, 2023

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share