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Impact of Endothelial and Leukocyte Senescence in Circulatory Shock States (Seneshock)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03559569
Recruitment Status : Recruiting
First Posted : June 18, 2018
Last Update Posted : September 14, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment
Shock Cardiovascular Diseases Infection Biological: Biological samples will be done to evaluate the endothelial and leukocyte senescence.

Study Design
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Study Type : Observational
Estimated Enrollment : 520 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Endothelial and Leukocyte Senescence in Circulatory Shock States
Actual Study Start Date : January 7, 2019
Estimated Primary Completion Date : February 2025
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Groups and Cohorts
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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
 Biological: Biological samples will be done to evaluate the endothelial and leukocyte senescence.
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.
 Biological: Biological samples will be done to evaluate the endothelial and leukocyte senescence.
Noninvasive, reproducible, and sensitive methods to measure cardiac function, endothelial function, and arterial stiffness will be assess.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Incidence of cardiovascular events and secondary infection in hospitalized patients in intensive care unit for circulatory shock states [ Time Frame: 5 years ]

Biospecimen Retention:   Samples With DNA
Only whole blood will be collected

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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"

Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03559569


Contacts
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Contact: Morgane CLERC 03 88 11 68 55 ext +33 morgane.clerc@chru-strasbourg.fr
Contact: Madoé JULIANS 03 88 11 61 86 ext +33 madoe.julians@chru-strasbourg.fr

Locations
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France
Hôpitaux Universitaires de Strasbourg - Service de Réanimation médicale du NHC Recruiting
Strasbourg, France, 67091
Contact: Ferhat MEZIANI    03 69 55 10 24 ext +33    ferhat.meziani@chru-strasbourg.fr   
Contact: Hamid MERDJI    03 69 55 11 23 ext +33    hamid.merdji@chru-strasbourg.fr   
Principal Investigator: Ferhat MEZIANI         
Sub-Investigator: Hamid MERDJI         
Sub-Investigator: Laure STIEL         
Sub-Investigator: Xavier DELABRANCHE         
Sub-Investigator: Christine KUMMERLEN         
Sub-Investigator: Hassène RAHMANI         
Sub-Investigator: Alexandra MONNIER         
Sub-Investigator: Yannick RABOUEL         
Sub-Investigator: Julie HELMS         
Sub-Investigator: Raphaël CLERE-JEHL         
Sub-Investigator: Dominique STEPHAN         
Sub-Investigator: Sébastien GAERTNER         
Sub-Investigator: Catherine MUTTER         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
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Principal Investigator: Ferhat MEZIANI Hôpitaux Universitaires de Strasbourg
More Information
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT03559569    
Other Study ID Numbers: 7031
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: September 14, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Strasbourg, France:
Shock
Cardiovascular Diseases
Infection
Additional relevant MeSH terms:
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Cardiovascular Diseases
Shock
Pathologic Processes