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

NCT ID: NCT04204694

Last Updated: 2021-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2023-04-01

Brief Summary

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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

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Conditions

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Septic Shock

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient in septic shock

3-time blood sampling for septic shock patients

Intervention Type OTHER

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

blood donor tests

Only one blood sampling for controls patients

Intervention Type OTHER

15 mL blood are sampled from a blood donation

Interventions

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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

Intervention Type OTHER

Only one blood sampling for controls patients

15 mL blood are sampled from a blood donation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Controls :
* Blood donors

Exclusion Criteria

* Moribund
* Age \< 18 years old
* Absence of written consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service de réanimation médicale

Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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7350

Identifier Type: -

Identifier Source: org_study_id

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