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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04204694

Acronym

INTERSEP

Enrollment

100

Registered

2019-12-19

Start date

2020-07-01

Completion date

2023-04-01

Last updated

2021-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic Shock

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

Interventions

OTHER3-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

OTHEROnly one blood sampling for controls patients

15 mL blood are sampled from a blood donation

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
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)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026