TerminatedNot Applicable

In Vivo Glycocalyx as Predictor of Complications After Cardiac Surgery

Stopped: The period of authorization for effective inclusion has ended at 130 inclusions out of a theoretical 600.

France130 participantsStarted 2020-11-30

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

association between preoperative sublingual glycocalyx thickness (glycocheck device) and major postoperative complications

Timeframe: 48 hours

Trial details

NCT IDNCT04643535

SponsorUniversity Hospital, Rouen

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-07-03

View on ClinicalTrials.gov More Endothelial Dysfunction trials