Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT04643535
Status:
UNKNOWN
Last Update Posted:
2020-12-24
First Post:
2020-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
In Vivo Glycocalyx as Predictor of Complications After Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-22', 'studyFirstSubmitDate': '2020-11-19', 'studyFirstSubmitQcDate': '2020-11-19', 'lastUpdatePostDateStruct': {'date': '2020-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'association between preoperative sublingual glycocalyx thickness (glycocheck device) and major postoperative complications', 'timeFrame': '48 hours', 'description': 'occurence within 48 postoperative hours of at least one item among:\n\n* vasoplegic shock\n* cardiogenic shock\n* prolonged mechanical ventilation\n* acute kidney failure\n* Death'}], 'secondaryOutcomes': [{'measure': 'association between preoperative sublingual glycocalyx thickness (glycocheck device) and death', 'timeFrame': '28 days', 'description': 'death from any causes'}, {'measure': 'association between preoperative sublingual glycocalyx thickness (glycocheck device) and cardiac arrythmia', 'timeFrame': '28 days', 'description': 'atrial or ventricular arrythmia'}, {'measure': 'association between preoperative sublingual glycocalyx thickness (glycocheck device) and Cerebral stroke', 'timeFrame': '28 days', 'description': 'ischemic of hemorrhagic etiology'}, {'measure': 'association between preoperative sublingual glycocalyx thickness (glycocheck device) and cognitive dysfunction', 'timeFrame': '28 days', 'description': 'delirium or alteration of cognitive status'}, {'measure': 'association between preoperative sublingual glycocalyx thickness (glycocheck device) and myocardial ischemia', 'timeFrame': '28 days', 'description': 'occurence of ischemia: new Q wave, new occlusion of a coronary arteria, elevated troponinemia with a new dysfunction of at least one myocardial segment'}, {'measure': 'association between preoperative sublingual glycocalyx thickness (glycocheck device) and acute respiratory failure', 'timeFrame': '28 days', 'description': 'need for at least 5L/min of oxygen or non invasive ventilation of reintubation'}, {'measure': 'association between preoperative sublingual glycocalyx thickness (glycocheck device) and sepsis', 'timeFrame': '28 days', 'description': 'new sepsis condition as defined by SEPSIS-3 definition'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endothelial Dysfunction', 'Cardiovascular Diseases', 'Surgery']}, 'descriptionModule': {'briefSummary': '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.\n\nThus the preoperative alteration of glycocalyx may be associated with postoperative organ failure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients benefiting from cardiac surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients benefiting from a cardiac surgery with cardio-pulmonary bypass\n\nExclusion Criteria:\n\n* impossibility to carry out the measurement by glycocheck device\n* refusal to participate'}, 'identificationModule': {'nctId': 'NCT04643535', 'acronym': 'GLYPOCS', 'briefTitle': 'In Vivo Glycocalyx as Predictor of Complications After Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Rouen'}, 'officialTitle': 'Glycocalyx as Predictor of Complications After Cardiac Surgery', 'orgStudyIdInfo': {'id': '2020/202/OB'}}, 'contactsLocationsModule': {'locations': [{'zip': '76000', 'city': 'Rouen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'emmanuel besnier, MD', 'role': 'CONTACT', 'email': 'emmanuel.besnier@chu-rouen.fr', 'phone': '+33 2 32 88 17 05'}], 'facility': 'Rouen University Hospital', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'centralContacts': [{'name': 'Emmanuel Besnier, MD PhD', 'role': 'CONTACT', 'email': 'emmanuel.besnier@chu-rouen.fr', 'phone': '+33232881705'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Rouen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}