Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-06-26 @ 4:38 AM
Study NCT ID:
NCT04204694
Status:
UNKNOWN
Last Update Posted:
2021-09-14
First Post:
2019-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Role of Interferon αon the Endothelial Dysfunction During Septic Shock
Sponsor:
University Hospital, Strasbourg, France
Organization:
Study Overview
Official Title:
Study of the Role of Interferon αon the Endothelial Dysfunction During Septic Shock
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
ACTIVE_NOT_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:
INTERSEP
Brief Summary:
Septic shock is the most severe form of a bacterial infection, affecting 24 million patients per year worldwide, with a high mortality (\> 30%).
Septic shock is defined by an acute circulatory failure, with low blood pressure and insufficient oxygen supply to organs. This circulatory failure is related to vascular damages, in which the endothelial vascular tissue is impaired by inflammatory mechanisms, with release of circulating endothelial cells in the blood.
Therefore, modulating inflammation on the vascular endothelial tissue could be a therapeutic strategy, and the investigators focus on the role of the type I interferons on the endothelial tissue because of the demonstrated role of type I interferons during septic shock.
Thus the investigators proceed to an observational study, in which the primary purpose will be to show a higher expression of type I interferon receptors on circulating endothelial cells in patients with septic shock compared to control subjects.
Concerning secondary purposes, the investigators will record mortality at d3, d7 and d28, perform assays about types I, II and III interferons in plasma, and test anti-interferon on endothelial cells ex vivo
Septic shock is defined by an acute circulatory failure, with low blood pressure and insufficient oxygen supply to organs. This circulatory failure is related to vascular damages, in which the endothelial vascular tissue is impaired by inflammatory mechanisms, with release of circulating endothelial cells in the blood.
Therefore, modulating inflammation on the vascular endothelial tissue could be a therapeutic strategy, and the investigators focus on the role of the type I interferons on the endothelial tissue because of the demonstrated role of type I interferons during septic shock.
Thus the investigators proceed to an observational study, in which the primary purpose will be to show a higher expression of type I interferon receptors on circulating endothelial cells in patients with septic shock compared to control subjects.
Concerning secondary purposes, the investigators will record mortality at d3, d7 and d28, perform assays about types I, II and III interferons in plasma, and test anti-interferon on endothelial cells ex vivo
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: