Ignite Creation Date:
2024-05-06 @ 1:36 PM
Last Modification Date:
2024-10-26 @ 1:16 PM
Study NCT ID:
NCT04067674
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2019-08-22
Brief Title:
Septic Shock-induced Immunosuppression
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Evaluation of Immunosuppression in Septic Shock Biomarkers and Pharmacological Restoration
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
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 4
Brief Summary:
Septic syndromes are a major although largely under-recognized health care problem and represent the first cause of mortality in intensive care units ICU 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 immune 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 cytomegalovirus CMV or Herpes Simplex Virus 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 New promising therapeutic strategies are currently emerging from those recent findings such as adjunctive immunostimulation for the most immunosuppressed patients The prerequisite for immunostimulation administration Interferon gama IFNg Granulocyte Macrophage Colony Stimulating Factor GM-CSF interleukin 7 IL-7 however relies on clinicians capacity to identify patients who could benefit the most from these immunoadjuvant therapies as there is no clinical sign of immune dysfunctions
In this context the main objectives of IMMUNOSEPSIS 4 study are
1 to identify the best biomarkers for sepsis-induced immunosuppression
2 to evaluate ex vivo candidate treatments which could rejuvenate immune functions after septic shock
In this context the main objectives of IMMUNOSEPSIS 4 study are
1 to identify the best biomarkers for sepsis-induced immunosuppression
2 to evaluate ex vivo candidate treatments which could rejuvenate immune functions after septic shock
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None