Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-03-01 @ 12:04 PM
Study NCT ID:
NCT03197051
Status:
COMPLETED
Last Update Posted:
2019-01-11
First Post:
2017-06-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Perioperative Shedding of the Endothelial Glycocalyx on the Incidence of Postoperative Acute Kidney Injury in Patients Undergoing Valvular Heart Surgery.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-07-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-10', 'studyFirstSubmitDate': '2017-06-20', 'studyFirstSubmitQcDate': '2017-06-20', 'lastUpdatePostDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute kidney injury', 'timeFrame': 'Up to Postoperative 48 hours', 'description': 'Acute kidney injury is classified under KDIGO guideline.\n\nStage I\n\n* Serum creatinine (Scr) : 1.5 to 1.9 times baseline or ≥26μmol/L (≥3.0mg/dL) increase\n* Urine output : \\<0.5mL/kg/kr for 6\\~12hrs\n\nStage II\n\n* Serum creatinine (Scr) : 2.0 to 2.9 times baseline\n* Urine output : \\<0.5mL/kg/hr for ≥12hrs\n\nStage III\n\n* Serum creatinine (Scr) : 3.0 times baseline or ≥354μmol/L (≥4.0mg/dL) increase or Initiation for RRT\n* Urine output : \\<0.3mL/kg/hr for ≥24hrs or Anuria for ≥12hrs'}], 'secondaryOutcomes': [{'measure': 'Composite morbidity and mortality (by STS Major morbidity endpoint)', 'timeFrame': 'Up to postoperative 30 days', 'description': 'STS Major morbidity endpoint\n\n* Mortality for postoperative 30 days irrelevant to causes\n* Permanent stroke\n* Wound infection\n* Prolonged ventilation greater than 48 hours\n* Cardiac surgery reoperation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endothelial glycocalyx', 'Acute kidney injury', 'Valvular heart disease'], 'conditions': ['Valvular Heart Disease']}, 'descriptionModule': {'briefSummary': 'Endothelial glycocalyx, the luminal structure of healthy vasculature, plays critical roles in regulation of inflammatory responses, vascular permeability, blood coagulation. It can be easily damaged by ischemia/reperfusion, hypoxemia, oxidative stress, endotoxin. Accordingly, the relationship between the shedding of endothelial glycocalyx and the prognosis of diseases such as diabetes mellitus, atherosclerosis, malignancy has been researched.\n\nIn cases of cardiac surgery, patients cannot help but be exposed to ischemia/reperfusion, oxidative stress which can damage endothelial glycocalyx. In this research, the investigators would like to discover the impact of perioperative shedding of the endothelial glycocalyx on the incidence of postoperative acute kidney injury in patients undergoing valvular heart surgery.', 'detailedDescription': 'Syndecan-1, Heparan sulfate serve as biomarkers of glycocalyx degradation. Both biomarkers will be measured 2 times, before the anesthetic induction, and immediately after weaning from cardiopulmonary bypass, during the valvular heart surgery.\n\nPostoperative acute kidney injury up to postoperative 48 hours, Composite morbidity and mortality up to postoperative 30 days will be checked.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing valvular heart surgery (\\>20 years old)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients undergoing valvular heart surgery (\\>20 years old)\n\nExclusion Criteria:\n\n* Emergency operation\n* Aorta surgery (Graft replacement of Total arch or Descending thoracic aorta)\n* Minimal invasive surgery\n* Chronic kidney disease (eGFR\\<30mL/min/1.73m2) / Dialysis history\n* Infective endocarditis\n* Malignancy\n* Patients who cannot give Informed consent (e.g. Illiterate, Foreigners)\n* Patients who are already enrolled to another study than can affect the results'}, 'identificationModule': {'nctId': 'NCT03197051', 'briefTitle': 'Impact of Perioperative Shedding of the Endothelial Glycocalyx on the Incidence of Postoperative Acute Kidney Injury in Patients Undergoing Valvular Heart Surgery.', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Impact of Perioperative Shedding of the Endothelial Glycocalyx on the Incidence of Postoperative Acute Kidney Injury in Patients Undergoing Valvular Heart Surgery.', 'orgStudyIdInfo': {'id': '4-2017-0340'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Q1', 'description': 'Measure the Concentration of Syndecan-1, Heparan sulfate before anesthetic induction and immediately after weaning from cardiopulmonary bypass. Categorize the patients by serum syndecan-1 concentration(off-CPB) quartile. Q1 means a group of lowest 25% of serum syndecan-1 concentration.'}, {'label': 'Q2', 'description': 'Q2 means a group of lower 25\\~50% of serum syndecan-1 concentration.'}, {'label': 'Q3', 'description': 'Q3 means a group of higher 50\\~75% of serum syndecan-1 concentration.'}, {'label': 'Q4', 'description': 'Q4 means a group of highest 75\\~100% of serum syndecan-1 concentration.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}