GLYPOCS: In Vivo Glycocalyx as Predictor of Complications After Cardiac Surgery

Sponsor

University Hospital, Rouen (Other)

Overall Status

Recruiting

CT.gov ID

NCT04643535

Collaborator

(none)

600

Enrollment

Location

Anticipated Duration (Months)

16.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endothelial Dysfunction Cardiovascular Diseases Surgery

Study Design

Study Type:

Observational

Anticipated Enrollment :

600 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Glycocalyx as Predictor of Complications After Cardiac Surgery

Actual Study Start Date :

Nov 30, 2020

Anticipated Primary Completion Date :

Nov 30, 2023

Anticipated Study Completion Date :

Dec 30, 2023

Outcome Measures

Primary Outcome Measures

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

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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rouen University Hospital	Rouen		France	76000

Sponsors and Collaborators

University Hospital, Rouen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Rouen

ClinicalTrials.gov Identifier:

NCT04643535

Other Study ID Numbers:

2020/202/OB

First Posted:

Nov 25, 2020

Last Update Posted:

Dec 24, 2020

Last Verified:

Nov 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cardiovascular Diseases

Study Results

No Results Posted as of Dec 24, 2020