In Vivo Glycocalyx as Predictor of Complications After Cardiac Surgery

• Conditions: Surgery; Endothelial Dysfunction; Cardiovascular Diseases

• Registration Number: NCT04643535
• Lead Sponsor: University Hospital, Rouen

Brief Summary

Cardiac surgery has been described as altering endothelium structure and function, notably because of the use of cardiac-pulmonary bypass (CPB). Among the endothelial structure, glycocalyx, the thin layer recovering the endothelial surface, may be altered by the inflammatory process and probably the modification of flow during CPB. Endothelial and glycocalyx integrity are essential for vascular function and glycocalyx destruction is associated with organ failure and mortality. On the other hand, a chronic alteration of glycocalyx is observed in many diseases such as diabetes, hypertension or chronic kidney failure, all pathologies frequently observed in patients benefiting grom cardiac surgery.

Thus the preoperative alteration of glycocalyx may be associated with postoperative organ failure.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-11
• Study First Submitted: 2020-11-19
• Study First Submitted QC: 2020-11-19
• Study First Posted: 2020-11-25
• Study Start: 2020-11-30
• Last Update Submitted: 2020-12-22
• Last Update Posted: 2020-12-24
• Primary Completion: 2023-11-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• all patients benefiting from a cardiac surgery with cardio-pulmonary bypass

Exclusion Criteria

• impossibility to carry out the measurement by glycocheck device
• refusal to participate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
association between preoperative sublingual glycocalyx thickness (glycocheck device) and major postoperative complications	48 hours	occurence within 48 postoperative hours of at least one item among: * vasoplegic shock; * cardiogenic shock; * prolonged mechanical ventilation; * acute kidney failure; * Death

Secondary Outcome Measures

Name	Time	Method
association between preoperative sublingual glycocalyx thickness (glycocheck device) and cognitive dysfunction	28 days	delirium or alteration of cognitive status
association between preoperative sublingual glycocalyx thickness (glycocheck device) and myocardial ischemia	28 days	occurence of ischemia: new Q wave, new occlusion of a coronary arteria, elevated troponinemia with a new dysfunction of at least one myocardial segment
association between preoperative sublingual glycocalyx thickness (glycocheck device) and acute respiratory failure	28 days	need for at least 5L/min of oxygen or non invasive ventilation of reintubation
association between preoperative sublingual glycocalyx thickness (glycocheck device) and sepsis	28 days	new sepsis condition as defined by SEPSIS-3 definition
association between preoperative sublingual glycocalyx thickness (glycocheck device) and death	28 days	death from any causes
association between preoperative sublingual glycocalyx thickness (glycocheck device) and cardiac arrythmia	28 days	atrial or ventricular arrythmia
association between preoperative sublingual glycocalyx thickness (glycocheck device) and Cerebral stroke	28 days	ischemic of hemorrhagic etiology

Trial Locations

Locations (1)

Rouen University Hospital; 🇫🇷 Rouen, France