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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03559569
Other study ID # 7031
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 7, 2019
Est. completion date March 2025

Study information

Verified date August 2023
Source University Hospital, Strasbourg, France
Contact Morgane CLERC
Phone 03 88 11 68 55
Email morgane.clerc@chru-strasbourg.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 520
Est. completion date March 2025
Est. primary completion date February 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
France Hôpitaux Universitaires de Strasbourg - Service de Réanimation médicale du NHC Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary The main criterion will be the acquisition of a senescent phenotype concerning leukocytes and endothelial cells. Biological samples will be done to evaluate the endothelial and leukocyte senescence. 1 year
Secondary Incidence of cardiovascular events and secondary infection in hospitalized patients in intensive care unit for circulatory shock states 5 years
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