Ignite Creation Date:
2024-05-06 @ 8:42 AM
Last Modification Date:
2024-10-26 @ 12:04 PM
Study NCT ID:
NCT02803346
Status:
UNKNOWN
Last Update Posted:
2016-06-16
First Post:
2016-06-14
Brief Title:
Evaluation of Immunosuppression in Septic Shock Biomarkers and Pharmacological Restoration IMMUNOSEPSIS
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Evaluation of Immunosuppression in Septic Shock Biomarkers and Pharmacological Restoration IMMUNOSEPSIS
Status:
UNKNOWN
Status Verified Date:
2016-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMMUNOSEPSIS
Brief Summary:
Septic syndromes systemic inflammatory response associated with infection remain a major although largely under-recognized health care problem and represent the first cause of mortality in intensive care units While it has long been known that sepsis deeply perturbs immune homeostasis by inducing a tremendous systemic inflammatory response novel findings indicate that sepsis indeed initiates a more complex immunologic response that varies over time with the concomitant occurrence of both pro- and anti-inflammatory mechanisms As a resultant after a short pro-inflammatory phase septic patients enter a stage of protracted immunosuppression This is illustrated in those patients by reactivation of dormant viruses CMV or HSV or infections due to pathogens including fungi which are normally pathogenic solely in immunocompromised hosts These alterations might be directly responsible for worsening outcome in patients who survived initial resuscitation as nearly all immune functions are deeply compromised Both arms of immunity innate and adaptive are indeed markedly suppressed including enhanced leukocyte apoptosis lymphocyte anergy and deactivated monocyte functions New promising therapeutic avenues are currently emerging from those recent findings such as adjunctive immunostimulation for the most immunosuppressed patients The prerequisite for immunostimulation administration IFNg GM-CSF IL-7 however relies on the investigators capacity in identifying the patients who could benefit from it as there is no clinical sign of immune dysfunctions The main objectives are
1 to identify the best biomarkers for sepsis-induced immunosuppression and
2 to evaluate ex vivo whether drugs could rejuvenate immune functions
1 to identify the best biomarkers for sepsis-induced immunosuppression and
2 to evaluate ex vivo whether drugs could rejuvenate immune functions
Detailed Description:
None
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