Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-26 @ 2:23 AM
Study NCT ID:
NCT01617902
Status:
UNKNOWN
Last Update Posted:
2012-06-18
First Post:
2012-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hyperbilirubinemia After Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006932', 'term': 'Hyperbilirubinemia'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2013-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-06-14', 'studyFirstSubmitDate': '2012-06-10', 'studyFirstSubmitQcDate': '2012-06-10', 'lastUpdatePostDateStruct': {'date': '2012-06-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All cause-death', 'timeFrame': 'Within 30 days after surgery or during postoperative hospitalization'}], 'secondaryOutcomes': [{'measure': 'gastrointestinal or hepatobiliary complications requiring intervention', 'timeFrame': 'Within 30 days after surgery or during postoperative hospitalization'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hyperbilirubinemia', 'cardiac', 'surgery', 'aorta', 'prognosis'], 'conditions': ['Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the incidence and risk factors of hyperbilirubinemia following major cardiac or thoracic aorta surgery, and to determine the clinical impacts of the hyperbilirubinemia on postoperative mortality and morbidity.', 'detailedDescription': 'Patients receiving elective cardiac or thoracic aorta surgery will be monitored for the development of postoperative hyperbilirubinemia. Collection of data will include patient baseline demographic characteristics, laboratory and echocardiographic findings, procedural factors of the surgery, and early postoperative variables. Serial postoperative liver function testings will be done during the hospitalization. Postoperative hyperbilirubinemia is defined as serum bilirubin level of 3mg/dL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing elective major cardiac or thoracic aorta surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients aged over 18 years who are scheduled to undergo elective major cardiac or thoracic aorta surgery. Major cardiac surgery includes coronary artery bypass grafting, pericardiectomy and corrections of cardiac diseases using cardiopulmonary bypassing (valve surgery, tumor excision, arrhythmia surgery, heart transplantation, ventricular reconstruction, pulmonary thromboembolectomy, and atrial or ventricular septal defects closure).\n\nExclusion Criteria:\n\n1. univentricular or one-and-half ventricle repairs\n2. presence of known liver cirrhosis or hepatic cancer\n3. history of liver transplantation\n4. Genetic diseases that affects bilirubin metabolism (i.e. Gilbert syndrome)\n5. preoperative bilirubin level of 3mg/dL or more.'}, 'identificationModule': {'nctId': 'NCT01617902', 'briefTitle': 'Hyperbilirubinemia After Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Hyperbilirubinemia After Major Cardiac or Thoracic Aorta Surgery: Predictors and Clinical Significance', 'orgStudyIdInfo': {'id': 'HBCS_01'}}, 'contactsLocationsModule': {'locations': [{'zip': '138-736', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Joon Bum Kim, MD', 'role': 'CONTACT', 'email': 'jbkim1975@amc.seoul.kr', 'phone': '82-2-3010-5416'}], 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Joon Bum Kim, MD', 'role': 'CONTACT', 'email': 'jbkim1975@amc.seoul.kr', 'phone': '82-2-3010-5416'}], 'overallOfficials': [{'name': 'Joon Bum Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Joon Bum Kim', 'investigatorAffiliation': 'Asan Medical Center'}}}}