Septic ShockINTERSEPNCT04204694
Study of the Role of Interferon αon the Endothelial Dysfunction During Septic Shock
An observational study of Septic Shock, run by University Hospital, Strasbourg, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- 3-time blood sampling for septic shock patients
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2020to 1 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
None listed.
Who cannot join
- Moribund
- Age < 18 years old
- Absence of written consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- 3-time blood sampling for septic shock patients, Only one blood sampling for controls patients
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-time blood sampling for septic shock patientsOther
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 patientsOther
15 mL blood are sampled from a blood donation
| Study group | Role | What they receive |
|---|---|---|
| Patient in septic shock | Not described Receives: Other: 3-time blood sampling for septic shock patients | |
| blood donor tests | Not described Receives: Other: Only one blood sampling for controls patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of the activated interferon-α receptors (IFNAR) by circulant endothelial cells
Measured: Within 12 hours following the onset of norepinephrin for septic shock (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start1 Jul 2020
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04204694
- Sponsor's protocol ID
- 7350
- Acronym
- INTERSEP
- Status last verified
- Sep 2021
- First submitted
- 16 Dec 2019
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Role of Interferon αon the Endothelial Dysfunction During Septic Shock
- ClinicalTrials.gov ID
- NCT04204694
- Acronym / sponsor ID
- INTERSEP / 7350
- Conditions
- Septic Shock
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 19 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient in septic shock | – | Other: 3-time blood sampling for septic shock patients |
| blood donor tests | – | Other: Only one blood sampling for controls patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Moribund
- Age < 18 years old
- Absence of written consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3-time blood sampling for septic shock patients15 mL blood are sampled at day1, day 3 and day 7, from the arterial catheter inserted for all patients with septic shock | Other | Patient in septic shock |
| Only one blood sampling for controls patients15 mL blood are sampled from a blood donation | Other | blood donor tests |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.