In Vivo Glycocalyx as Predictor of Complications After Cardiac Surgery

Cardiovascular Diseases Clinical Trial

— GLYPOCS  

Official title:

Glycocalyx as Predictor of Complications After Cardiac Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04643535
• Other study ID #: 2020/202/OB
• Status: Recruiting
• Start date: November 30, 2020
• Est. completion date: December 30, 2023

Study information

• Verified date: November 2020
• Source: University Hospital, Rouen
• Contact: Emmanuel Besnier, MD PhD
• Phone: +33232881705
• Email: emmanuel.besnier[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Endothelial Dysfunction
• Surgery

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

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 preoperative sublingual glycocalyx thickness (glycocheck device) and major postoperative complications	occurence within 48 postoperative hours of at least one item among: vasoplegic shock; cardiogenic shock; prolonged mechanical ventilation; acute kidney failure; Death	48 hours
Secondary	association between preoperative sublingual glycocalyx thickness (glycocheck device) and death	death from any causes	28 days
Secondary	association between preoperative sublingual glycocalyx thickness (glycocheck device) and cardiac arrythmia	atrial or ventricular arrythmia	28 days
Secondary	association between preoperative sublingual glycocalyx thickness (glycocheck device) and Cerebral stroke	ischemic of hemorrhagic etiology	28 days
Secondary	association between preoperative sublingual glycocalyx thickness (glycocheck device) and cognitive dysfunction	delirium or alteration of cognitive status	28 days
Secondary	association between preoperative sublingual glycocalyx thickness (glycocheck device) and myocardial ischemia	occurence of ischemia: new Q wave, new occlusion of a coronary arteria, elevated troponinemia with a new dysfunction of at least one myocardial segment	28 days
Secondary	association between preoperative sublingual glycocalyx thickness (glycocheck device) and acute respiratory failure	need for at least 5L/min of oxygen or non invasive ventilation of reintubation	28 days
Secondary	association between preoperative sublingual glycocalyx thickness (glycocheck device) and sepsis	new sepsis condition as defined by SEPSIS-3 definition	28 days