Cardiac Surgical Procedures Clinical Trial
— Vaso-shockOfficial title:
In Situ Exploration of Vascular Function in Vasoplegic Shock Following Cardiac Surgery With Cardiopulmonary Bypass
NCT number | NCT06318689 |
Other study ID # | 2023/0211/OB |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | February 5, 2024 |
Est. completion date | May 5, 2026 |
The goal of this observational study is to assess in situ vascular function, glycocalyx and microcirculation in postoperative vasoplegic shock following cardiac surgery with cardiopulmonary bypass. The main question is to investigate the relationship between NO-dependent vasomotor reserve and the presence of vasoplegic shock following cardiac surgery with cardiopulmonary bypass. Participants will have two visits, during which a number of non-invasive examinations will be carried out to study glycocalyx, microcirculation and vascular function. Biological and morphological data will be collected up to 3 months after inclusion, as well as information on treatments administered and outcome. Researchers will compare a group of patients with vasoplegic shock against a group without vasoplegic shock in order to study possible alterations in function in the vasoplegic shock group.
Status | Recruiting |
Enrollment | 124 |
Est. completion date | May 5, 2026 |
Est. primary completion date | February 5, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Patients aged between 18 and 80 years old - Patient undergoing cardiac surgery with cardiopulmonary bypass - Hospitalised in a cardiac surgical unit, between 4 and 24 hours after the end of cardiopulmonary bypass, after volemic optimisation Exclusion Criteria: - Sepsis at inclusion - Cardiac transplant - Circulatory assistance - Known alteration of the microcirculation - Any condition contraindicating measurement via Glycocheck or flux mediated dilatation measurement - New surgery within 48 hours of the operation - Person deprived of liberty by an administrative or judicial decision or person placed under legal protection / sub-guardianship or guardianship - Patient refusal |
Country | Name | City | State |
---|---|---|---|
France | Rouen University Hospital | Rouen | Normandie |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Rouen |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Association between the percentage of brachial artery variation measured by the flow-mediated vasodilation method and the presence of vasoplegic shock at incusion. | Association between the percentage of brachial artery variation measured by the flow-mediated vasodilation method and the presence of vasoplegic shock. | At inclusion | |
Secondary | Association between the percentage of brachial artery variation measured by the flow-mediated vasodilation method and the presence of vasoplegic shock at 48 hours. | Association between the percentage of brachial artery variation measured by the flow-mediated vasodilation method and the presence of vasoplegic shock. | At 48 hours | |
Secondary | Pefused boundary region (PBR, µm) obtained from Glycocheck with the presence of vasoplegic shock. | Pefused boundary region is an index given by the Glycocheck, a reflection of the alteration of the glycocalyx.
The higher the value, the more impaired the glycocayx. |
At inclusion and at 48 hours | |
Secondary | Microvascular blood flow (10^3 microns^3 / sec / mm^2) obtained from Glycocheck with the presence of vasoplegic shock | Microvascular blood flow (10^3 microns^3 / sec / mm^2), given by the Glycocheck, is an estimation of the microcirculation. The lower the value, the more it indicates a deterioration in microcirculation. | At inclusion and at 48 hours | |
Secondary | Total density (number of 10 micron long vessel segments with diameter of 4 to 25 microns per tissue surface area /mm^2) obtained from Glycocheck with the presence of vasoplegic shock | Total density (number of 10 micron long vessel segments with diameter of 4 to 25 microns per tissue surface area /mm^2), given by the Glycocheck, is an estimation of the density ot the vessels. The lower the value, the more it indicates a deterioration in microcirculation. | At inclusion and at 48 hours | |
Secondary | Endothelial function markers (Endothelin-1, pg/mL) with the presence of vasoplegic shock | Endothelin-1 (pg/ml), indicates vasoconstriction, will be measured by ELISA. | At inclusion and at 48 hours | |
Secondary | Endothelial function markers (syndecan-1, pg/mL) with the presence of vasoplegic shock | Endothelin-1 (pg/ml), indicates endothelium ateration, will be measured by ELISA. | At inclusion and at 48 hours | |
Secondary | Endothelial function markers (interleukin-6, pg/mL) with the presence of vasoplegic shock | Interleukin-6 (pg/ml), indicates inflammation, will be measured by ELISA. | At inclusion and at 48 hours | |
Secondary | Endothelial function markers (VCAM-1, pg/mL) with the presence of vasoplegic shock | VCAM-1 (pg/ml), indicates endothelium ateration, will be measured by ELISA. | At inclusion and at 48 hours | |
Secondary | Multivariate analysis explaining the occurrence of vasoplegic shock. | Model constructed from variables found to be associated in univariate analysis. | At inclusion and at 48 hours | |
Secondary | Multivariate analysis explaining the occurrence of an altered perfused boundary region (µm). | Model constructed from variables found to be associated in univariate analysis. | At inclusion and at 48 hours |
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