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Withdrawn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
About this trial
This is an interventional basic science trial for Septic Shock
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
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
NCT ID
NCT04320394
First Posted
March 23, 2020
Last Updated
July 24, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
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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