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

NCT06318689 | Recruiting

• 1 other identifier: 2023/0211/OB
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiac Surgical Procedures

Keywords

Cardiopulmonary Bypass; Vasoplegia; Glycocalyx; Vascular function

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Association between the percentage of brachial artery variation measured by the flow-mediated vasodilation method and the presence of vasoplegic shock at 48 hours.

  At 48 hours

• Pefused boundary region (PBR, µm) obtained from Glycocheck with the presence of vasoplegic shock.

  At inclusion and at 48 hours

• Microvascular blood flow (10^3 microns^3 / sec / mm^2) obtained from Glycocheck with the presence of vasoplegic shock

  At inclusion and at 48 hours

• 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

  At inclusion and at 48 hours

• Endothelial function markers (Endothelin-1, pg/mL) with the presence of vasoplegic shock

  At inclusion and at 48 hours

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged between 18 and 80 years old hospitalised in the cardiac intensive care unit after cardiac surgery requiring cardiopulmonary bypass.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Rouen University Hospital

Rouen, Normandy, 76000, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be collected using 1 tube of 5 mL EDTA at inclusion and at 48 hours.

MeSH Terms

Conditions

Vasoplegia

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Emmanuel EB BESNIER, PHD

  CHU Rouen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emmanuel EB BESNIER, PHD

CONTACT

02 32 88 89 90; emmanuel.besnier@chu-rouen.fr

Domitille DR RENARD, MD

CONTACT

02 32 88 89 90; domitille.renard@chu-rouen.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 19, 2024
• Study Start: February 5, 2024
• Primary Completion: February 5, 2026
• Study Completion: May 5, 2026
• Last Updated: March 19, 2024

Record last verified: 2024-02

Locations

FR (1)