Study of the Role of Interferon αon the Endothelial Dysfunction During Septic Shock (INTERSEP)

September 13, 2021 updated by: University Hospital, Strasbourg, France

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67000
        • Service de réanimation médicale

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient in septic shock
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
blood donor tests
Other: Only one blood sampling for controls patients
15 mL blood are sampled from a blood donation

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

December 16, 2019

First Submitted That Met QC Criteria

December 16, 2019

First Posted (Actual)

December 19, 2019

Study Record Updates

Last Update Posted (Actual)

September 14, 2021

Last Update Submitted That Met QC Criteria

September 13, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7350

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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