In Situ Exploration of Vascular Function in Vasoplegic Shock Following Cardiac Surgery With Cardiopulmonary Bypass

Cardiac Surgical Procedures Clinical Trial

— Vaso-shock  

Official title:

In Situ Exploration of Vascular Function in Vasoplegic Shock Following Cardiac Surgery With Cardiopulmonary Bypass

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06318689
• Other study ID #: 2023/0211/OB
• Status: Recruiting
• Start date: February 5, 2024
• Est. completion date: May 5, 2026

Study information

• Verified date: February 2024
• Source: University Hospital, Rouen
• Contact: Emmanuel EB BESNIER, PHD
• Phone: 02 32 88 89 90
• Email: emmanuel.besnier[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

Objective : the primary objective of this study is to explore in situ the glycocalyx, the microcirculation and vascular function in postoperative vasoplegic shock following cardiac surgery with CPB. Secondary objectives are to study links between vascular function and damage to the glycocalyx and microcirculation and patient prognosis, in particular their impact on fluid balance.

Method :

Constitution of a single-centre prospective cohort study of 124 patients. Patients hospitalised in the cardiac intensive care unit after cardiac surgery with CPB will be consecutively included from 4 to 24 hours after surgery: 62 patients with vasoplegic shock (noradrenaline > 0.05µg/kg/min for at least 4 hours and after correction of any hypovolaemia), 62 patients without vasoplegic shock.

Endothelial function will be assessed using the flow-mediated dilation (FMD) method to test brachial artery vasodilation mediated by nitric oxide (NO) after induced ischemia. Microcirculation and glycocalyx will be evaluated using GlycoCheck, providing several measurements of microcirculation and glycocalyx using Sidestream Dark Field technology (mucosal illumination by a green LED and continuous x20 magnification video recording at the sublingual mucosa level). Various endothelial and inflammatory markers will also be measured (VCAM-1, syndecan, endothelin, interleukin-6).

Each patient will be assessed at inclusion and 48 hours using GlycoCheck, FMD, and endothelial measurements, then followed through their medical records for 90 days, where a follow-up call will be conducted to assess outcomes. Collected information will include routine care data (morphological data, vital signs, laboratory tests, fluid balance, scores, treatments, surgical data).

Both groups will be compared using statistical tests, and risk factors for developing vasoplegic shock will be explored through logistic regression. Univariable analysis followed by multivariable logistic regression with backward data inclusion will then be performed to identify risk factors for vasoplegic syndrome within the entire cohort (necessarily including FMD and GlycoCheck). A p-value <0.05 will be considered statistically significant.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cardiac Surgical Procedures

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen	Normandie

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

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