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Evaluation of Sepsis-induced Immunosuppression Base on QuantiFERON Monitor® in Septic Shock (MONITOR SEPSIS)

Primary Purpose

Septic Shock

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
QuantiFERON Monitor®
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Septic Shock

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Septic shock patients

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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®

    Secondary Outcome Measures

    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,

    Full Information

    First Posted
    March 23, 2020
    Last Updated
    July 24, 2023
    Sponsor
    Centre Hospitalier Universitaire de Nice
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04320394
    Brief Title
    Evaluation of Sepsis-induced Immunosuppression Base on QuantiFERON Monitor® in Septic Shock
    Acronym
    MONITOR SEPSIS
    Official Title
    Evaluation of Sepsis-induced Immunosuppression Base on QuantiFERON Monitor® in Patients Presenting to the Intensive Care Unit for Septic Shock
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    no participants enrolled
    Study Start Date
    July 1, 2020 (Actual)
    Primary Completion Date
    July 1, 2022 (Actual)
    Study Completion Date
    July 1, 2022 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Universitaire de Nice

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Septic Shock

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Monocentric, Open-Label prospective study
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Septic shock patients
    Arm Type
    Other
    Arm Description
    Patients with septic shock will be taken from an additional tube to analyze their immune response
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    QuantiFERON Monitor®
    Intervention Description
    The test will be realised to evaluate sepsis induced immunosuppression on patient with septic shock
    Primary Outcome Measure Information:
    Title
    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®
    Description
    Use of an objective and functional immunological test measuring the production of IFN-γ, the QuantiFERON Monitor®
    Time Frame
    24 months
    Secondary Outcome Measure Information:
    Title
    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.
    Description
    the value of IFN - γ (UI/mL) in the plasma will be mesured after stimulation of the immune cells,
    Time Frame
    24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    no data sharing plan is planned

    Learn more about this trial

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

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