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

NCT04204694 | Unknown

• 1 other identifier: 7350
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Patient in septic shock

Other: 3-time blood sampling for septic shock patients

blood donor tests

Other: Only one blood sampling for controls patients

Interventions

3-time blood sampling for septic shock patients OTHER

15 mL blood are sampled at day1, day 3 and day 7, from the arterial catheter inserted for all patients with septic shock

Patient in septic shock

Only one blood sampling for controls patients OTHER

15 mL blood are sampled from a blood donation

blood donor tests

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will have two groups : 1. Patients with septic shock hospitalized in the ICU from Strasbourg University Hospital 2. Controls: blood donors recruited by the French blood establishment

You may not qualify if:

• Moribund
• Age \< 18 years old
• Absence of written consent

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service de réanimation médicale

Strasbourg, 67000, France

Location

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: December 19, 2019
• Study Start: July 1, 2020
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2023
• Last Updated: September 14, 2021

Record last verified: 2021-09

Locations

FR (1)