Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06549374
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Kinetics of INF-γ Production in Intensive Care Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Kinetics of INF-γ Production in Intensive Care Patients-Monitoring of INF-γ in Intensive Care
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IGREY
Brief Summary:
Most patients admitted to intensive care after severe trauma high-risk surgery or acute respiratory distress are frequently characterized by significant initial inflammation accompanied by a compensatory anti-inflammatory response which can lead to profound post-aggressive immunosuppression This immunosuppression is associated with an increased risk of nosocomial infections viral reactivations prolonged ICU stays and ultimately increased mortality Consequently immunostimulation with agents such as interferon gamma IFN-γ has been proposed as a means to restore immune defense in the most severe patients However in a recent study conducted on mechanically ventilated patients with acute organ failure treatment with interferon gamma-1b compared to placebo did not significantly reduce the incidence of nosocomial pneumonia or 28-day mortality and was even associated with an increase in severe side effects leading to the premature termination of the trial These results along with previous studies suggest that for IFN-γ to be effective it must be targeted at patients who have reached the immunosuppressive phase In the absence of evident clinical signs the use of biomarkers could guide clinicians in identifying the appropriate patients and the optimal timing for this therapy
In a recent monocentric study they evaluated a new automated IFN-γ assay on a cohort of 22 septic patients to monitor T lymphocyte functionality independently of antigen As expected the results showed a marked decrease in IFN-γ release which correlated with altered classical cellular parameters CD8 T cells mHLA-DR Since the test is performed using whole blood requires no technician intervention and provides results within four hours this project propose to characterize the evolution of the immune status of a large cohort of ICU patients including those with severe trauma high-risk surgery or acute respiratory distress syndrome
In a recent monocentric study they evaluated a new automated IFN-γ assay on a cohort of 22 septic patients to monitor T lymphocyte functionality independently of antigen As expected the results showed a marked decrease in IFN-γ release which correlated with altered classical cellular parameters CD8 T cells mHLA-DR Since the test is performed using whole blood requires no technician intervention and provides results within four hours this project propose to characterize the evolution of the immune status of a large cohort of ICU patients including those with severe trauma high-risk surgery or acute respiratory distress syndrome
Detailed Description:
Most patients admitted to intensive care after severe trauma high-risk surgery or acute respiratory distress are frequently characterized by significant initial inflammation accompanied by a compensatory anti-inflammatory response which can lead to profound post-aggressive immunosuppression This immunosuppression is associated with an increased risk of nosocomial infections viral reactivations prolonged ICU stays and ultimately increased mortality Consequently immunostimulation with agents such as interferon gamma IFN-γ has been proposed as a means to restore immune defense in the most severe patients However in a recent study conducted on mechanically ventilated patients with acute organ failure treatment with interferon gamma-1b compared to placebo did not significantly reduce the incidence of nosocomial pneumonia or 28-day mortality and was even associated with an increase in severe side effects leading to the premature termination of the trial These results along with previous studies suggest that for IFN-γ to be effective it must be targeted at patients who have reached the immunosuppressive phase In the absence of evident clinical signs the use of biomarkers could guide clinicians in identifying the appropriate patients and the optimal timing for this therapy
Among the described immune alterations and associated biomarkers in critically ill patients the decrease in Human Leukocyte Antigen HLA-DR expression on monocytes mHLA-DR has been studied more extensively and is now considered a reliable biomarker for guiding myeloid-targeted immunotherapies While functional tests are the best means to explore acquired immunosuppression in the ICU as they directly measure the capacity of a given cell population to respond to an in vitro stimulus they present analytical obstacles to their deployment Most protocols are homemade and lack standardization which is a major obstacle to large-scale trials and their use in clinical practice
In a recent monocentric study they evaluated a new automated IFN-γ assay on a cohort of 22 septic patients to monitor T lymphocyte functionality independently of antigen As expected the results showed a marked decrease in IFN-γ release which correlated with altered classical cellular parameters CD8 T cells mHLA-DR Since the test is performed using whole blood requires no technician intervention and provides results within four hours this project propose to characterize the evolution of the immune status of a large cohort of ICU patients including those with severe trauma high-risk surgery or acute respiratory distress syndrome
Among the described immune alterations and associated biomarkers in critically ill patients the decrease in Human Leukocyte Antigen HLA-DR expression on monocytes mHLA-DR has been studied more extensively and is now considered a reliable biomarker for guiding myeloid-targeted immunotherapies While functional tests are the best means to explore acquired immunosuppression in the ICU as they directly measure the capacity of a given cell population to respond to an in vitro stimulus they present analytical obstacles to their deployment Most protocols are homemade and lack standardization which is a major obstacle to large-scale trials and their use in clinical practice
In a recent monocentric study they evaluated a new automated IFN-γ assay on a cohort of 22 septic patients to monitor T lymphocyte functionality independently of antigen As expected the results showed a marked decrease in IFN-γ release which correlated with altered classical cellular parameters CD8 T cells mHLA-DR Since the test is performed using whole blood requires no technician intervention and provides results within four hours this project propose to characterize the evolution of the immune status of a large cohort of ICU patients including those with severe trauma high-risk surgery or acute respiratory distress syndrome
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None