Study Stopped
The period of authorization for effective inclusion has ended at 130 inclusions out of a theoretical 600.
In Vivo Glycocalyx as Predictor of Complications After Cardiac Surgery
GLYPOCS
Glycocalyx as Predictor of Complications After Cardiac Surgery
1 other identifier
observational
130
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2020
CompletedFirst Posted
Study publicly available on registry
November 25, 2020
CompletedStudy Start
First participant enrolled
November 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 3, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2025
CompletedFebruary 18, 2026
February 1, 2026
3.6 years
November 19, 2020
February 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
association between preoperative sublingual glycocalyx thickness (glycocheck device) and death
28 days
association between preoperative sublingual glycocalyx thickness (glycocheck device) and cardiac arrythmia
28 days
association between preoperative sublingual glycocalyx thickness (glycocheck device) and Cerebral stroke
28 days
association between preoperative sublingual glycocalyx thickness (glycocheck device) and cognitive dysfunction
28 days
association between preoperative sublingual glycocalyx thickness (glycocheck device) and myocardial ischemia
28 days
- +2 more secondary outcomes
Eligibility Criteria
All patients benefiting from cardiac surgery
You may qualify if:
- all patients benefiting from a cardiac surgery with cardio-pulmonary bypass
You may not qualify if:
- impossibility to carry out the measurement by glycocheck device
- refusal to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rouen University Hospital
Rouen, 76000, France
MeSH Terms
Conditions
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2020
First Posted
November 25, 2020
Study Start
November 30, 2020
Primary Completion
July 3, 2024
Study Completion
December 30, 2025
Last Updated
February 18, 2026
Record last verified: 2026-02