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

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ClinicalTrials.gov Identifier: NCT04643535
Recruitment Status : Recruiting
First Posted : November 25, 2020
Last Update Posted : December 24, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

Study Description
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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
Endothelial Dysfunction Cardiovascular Diseases Surgery

Study Design
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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Glycocalyx as Predictor of Complications After Cardiac Surgery
Actual Study Start Date : November 30, 2020
Estimated Primary Completion Date : November 30, 2023
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. association between preoperative sublingual glycocalyx thickness (glycocheck device) and death [ Time Frame: 28 days ]
    death from any causes

  2. association between preoperative sublingual glycocalyx thickness (glycocheck device) and cardiac arrythmia [ Time Frame: 28 days ]
    atrial or ventricular arrythmia

  3. association between preoperative sublingual glycocalyx thickness (glycocheck device) and Cerebral stroke [ Time Frame: 28 days ]
    ischemic of hemorrhagic etiology

  4. association between preoperative sublingual glycocalyx thickness (glycocheck device) and cognitive dysfunction [ Time Frame: 28 days ]
    delirium or alteration of cognitive status

  5. 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

  6. 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

  7. association between preoperative sublingual glycocalyx thickness (glycocheck device) and sepsis [ Time Frame: 28 days ]
    new sepsis condition as defined by SEPSIS-3 definition


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients benefiting from cardiac surgery
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04643535


Contacts
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Contact: Emmanuel Besnier, MD PhD +33232881705 emmanuel.besnier@chu-rouen.fr

Locations
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France
Rouen University Hospital Recruiting
Rouen, France, 76000
Contact: emmanuel besnier, MD    +33 2 32 88 17 05    emmanuel.besnier@chu-rouen.fr   
Sponsors and Collaborators
University Hospital, Rouen
More Information
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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT04643535    
Other Study ID Numbers: 2020/202/OB
First Posted: November 25, 2020    Key Record Dates
Last Update Posted: December 24, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases