- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03559569
Impact of Endothelial and Leukocyte Senescence in Circulatory Shock States (Seneshock)
Circulatory shocks (CS) are life-threatening, acute organ dysfunction. Advances in critical care medicine have decreased early hospital mortality, increasing the number of surviving patients. Regrettably, these survivors are at increased risk of new infections but also of cardiovascular disease.
The investigators hypothesize that CS with multi-organ dysfunction is associated with premature senescence of endothelial cells and immune cells and promotes endothelial thrombogenicity and immunosenescence leading to cardiovascular disease and secondary infections.
The aim of this work is therefore to evaluate the contribution of endothelial and leucocytes senescence to the occurrence of secondary events (infectious and cardiovascular) in patients with a CS. It will provide a better understanding of the pathogenesis of cardiovascular and immune diseases following a CS, likely to guide new management strategies to prevent their occurrence.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Morgane CLERC
- Phone Number: +33 03 88 11 68 55
- Email: morgane.clerc@chru-strasbourg.fr
Study Contact Backup
- Name: Madoé JULIANS
- Phone Number: +33 03 88 11 61 86
- Email: madoe.julians@chru-strasbourg.fr
Study Locations
-
-
-
Strasbourg, France, 67091
- Recruiting
- Hôpitaux Universitaires de Strasbourg - Service de Réanimation médicale du NHC
-
Contact:
- Ferhat MEZIANI
-
Contact:
- Ferhat MEZIANI
- Phone Number: +33 03 69 55 10 24
- Email: ferhat.meziani@chru-strasbourg.fr
-
Contact:
- Hamid MERDJI
- Phone Number: +33 03 69 55 11 23
- Email: hamid.merdji@chru-strasbourg.fr
-
Contact:
- Julie HELMS
-
Contact:
- Hamid MERDJI
-
Contact:
- Laure STIEL
-
Contact:
- Xavier DELABRANCHE
-
Contact:
- Christine KUMMERLEN
-
Contact:
- Hassène RAHMANI
-
Contact:
- Alexandra MONNIER
-
Contact:
- Yannick RABOUEL
-
Contact:
- Raphaël CLERE-JEHL
-
Contact:
- Dominique STEPHAN
-
Contact:
- Sébastien GAERTNER
-
Contact:
- Catherine MUTTER
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
All patients admitted in the intensive care unit of the "Nouvel Hôpital Civil de Strasbourg" for a circulatory shock will be included.
Healthy volunteer will be included in our Clinical Investigation Center of the "Hôpitaux Universitaires de Strasbourg"
Description
Inclusion criteria:
- Circulatory shock
- patient with health care insurance
Exclusion criteria:
- Patients' refusal to participate in clinical research
- Pregnant woman
- Breastfeeding woman
- A patient with a protective order
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with circulatory shock
500 patients with circulatory shock hospitalize in ICU will be prospectively included to assess the effect of this pathology on the senescence phenotype
|
Noninvasive, reproducible, and sensitive methods to measure cardiac function, endothelial function, and arterial stiffness will be assess.
|
|
Healthy volunteers
20 healthy volunteers will be included to assess the effect of no pathology on the senescence phenotype.
|
Noninvasive, reproducible, and sensitive methods to measure cardiac function, endothelial function, and arterial stiffness will be assess.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The main criterion will be the acquisition of a senescent phenotype concerning leukocytes and endothelial cells.
Time Frame: 1 year
|
Biological samples will be done to evaluate the endothelial and leukocyte senescence.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Incidence of cardiovascular events and secondary infection in hospitalized patients in intensive care unit for circulatory shock states
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ferhat MEZIANI, Hopitaux universitaires de Strasbourg
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7031
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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