In Vivo Glycocalyx as Predictor of Complications After Cardiac Surgery (GLYPOCS)

December 22, 2020 updated by: University Hospital, Rouen

Glycocalyx as Predictor of Complications After Cardiac Surgery

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients benefiting from cardiac surgery

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
association between preoperative sublingual glycocalyx thickness (glycocheck device) and major postoperative complications
Time Frame: 48 hours

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
association between preoperative sublingual glycocalyx thickness (glycocheck device) and death
Time Frame: 28 days
death from any causes
28 days
association between preoperative sublingual glycocalyx thickness (glycocheck device) and cardiac arrythmia
Time Frame: 28 days
atrial or ventricular arrythmia
28 days
association between preoperative sublingual glycocalyx thickness (glycocheck device) and Cerebral stroke
Time Frame: 28 days
ischemic of hemorrhagic etiology
28 days
association between preoperative sublingual glycocalyx thickness (glycocheck device) and cognitive dysfunction
Time Frame: 28 days
delirium or alteration of cognitive status
28 days
association between preoperative sublingual glycocalyx thickness (glycocheck device) and myocardial ischemia
Time Frame: 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
28 days
association between preoperative sublingual glycocalyx thickness (glycocheck device) and acute respiratory failure
Time Frame: 28 days
need for at least 5L/min of oxygen or non invasive ventilation of reintubation
28 days
association between preoperative sublingual glycocalyx thickness (glycocheck device) and sepsis
Time Frame: 28 days
new sepsis condition as defined by SEPSIS-3 definition
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2020

Primary Completion (Anticipated)

November 30, 2023

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

November 19, 2020

First Submitted That Met QC Criteria

November 19, 2020

First Posted (Actual)

November 25, 2020

Study Record Updates

Last Update Posted (Actual)

December 24, 2020

Last Update Submitted That Met QC Criteria

December 22, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020/202/OB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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