Study of the Role of Interferon αon the Endothelial Dysfunction During Septic Shock

• Conditions: Septic Shock
• Interventions: Other: 3-time blood sampling for septic shock patients; Other: Only one blood sampling for controls patients

• Registration Number: NCT04204694
• Lead Sponsor: University Hospital, Strasbourg, France

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-16
• Study First Submitted QC: 2019-12-16
• Study First Posted: 2019-12-19
• Study Start: 2020-07-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-13
• Last Update Posted: 2021-09-14
• Primary Completion: 2022-04-01
• Study Completion: 2023-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient in septic shock	3-time blood sampling for septic shock patients	-
blood donor tests	Only one blood sampling for controls patients	-

Primary Outcome Measures

Name	Time	Method
Expression of the activated interferon-α receptors (IFNAR) by circulant endothelial cells	Within 12 hours following the onset of norepinephrin for septic shock (day 1)

Trial Locations

Locations (1)

Service de réanimation médicale; 🇫🇷 Strasbourg, France