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

Septic Shock Clinical Trial

— INTERSEP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04204694
• Other study ID #: 7350
• Status: Active, not recruiting
• Start date: July 1, 2020
• Est. completion date: April 1, 2023

Study information

• Verified date: September 2021
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• For all subjects

• Age > 18 years old

• For females: negative pregnancy test

• Subject covered by health insurance

• Written consent

• Patients with septic shock

• Patients must be in ICU

• Septic shock defined by the Sepsis-3 criteria [1]

• Inclusion within the 12 hours following the onset of norepinephrin

• Controls :

• Blood donors

Exclusion criteria:

• Moribund

• Age < 18 years old

• Absence of written consent

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Other:
• 3-time blood sampling for septic shock patients
15 mL blood are sampled at day1, day 3 and day 7, from the arterial catheter inserted for all patients with septic shock
• Only one blood sampling for controls patients
15 mL blood are sampled from a blood donation

Locations

Country	Name	City	State
France	Service de réanimation médicale	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expression of the activated interferon-a receptors (IFNAR) by circulant endothelial cells		Within 12 hours following the onset of norepinephrin for septic shock (day 1)