Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2025-12-27 @ 9:40 PM
Study NCT ID:
NCT01713192
Status:
COMPLETED
Last Update Posted:
2015-11-18
First Post:
2012-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry for Perioperative Data in Patients Undergoing Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-16', 'studyFirstSubmitDate': '2012-10-22', 'studyFirstSubmitQcDate': '2012-10-23', 'lastUpdatePostDateStruct': {'date': '2015-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'perioperative data', 'timeFrame': '1 year after surgery', 'description': 'To obtain the perioperative data in patients undergoing cardiac surgery. Data will be collected including demographics, surgery and postoperative complications.\n\nIn addition, laboratory data such as coagulation and cytokine will be obtained. Intraoperative monitoring including bispectral index, cerebral oximeter, tissue oxygen saturation \\[InspectraTM StO2 (Hutchinson Technology Inc., MN, USA)\\], cardiac index \\[FloTrac/EV1000 (Edwards Lifesciences, Irvine, CA, USA), VolumeView/EV1000 (Edwards Lifesciences, Irvine, CA, USA), Vigilance II (Edwards Lifesciences, Irvine, CA, USA)\\] and mixed venous oxygen saturation will be evaluated.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cardiac Surgical Procedures', 'Anesthesia']}, 'referencesModule': {'references': [{'pmid': '26429135', 'type': 'DERIVED', 'citation': 'Cho YJ, Koo CH, Kim TK, Hong DM, Jeon Y. Comparison of cardiac output measures by transpulmonary thermodilution, pulse contour analysis, and pulmonary artery thermodilution during off-pump coronary artery bypass surgery: a subgroup analysis of the cardiovascular anaesthesia registry at a single tertiary centre. J Clin Monit Comput. 2016 Dec;30(6):771-782. doi: 10.1007/s10877-015-9784-6. Epub 2015 Oct 1.'}, {'pmid': '26337035', 'type': 'DERIVED', 'citation': 'Kim TK, Cho YJ, Min JJ, Murkin JM, Bahk JH, Hong DM, Jeon Y. Microvascular reactivity and clinical outcomes in cardiac surgery. Crit Care. 2015 Sep 4;19(1):316. doi: 10.1186/s13054-015-1025-3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this registry is to obtain perioperative data in patients undergoing cardiac surgery and find out relations between the data and investigate several causes affecting postoperative complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing cardiac surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing cardiac surgery\n\nExclusion Criteria:\n\n* refused to participate'}, 'identificationModule': {'nctId': 'NCT01713192', 'briefTitle': 'Registry for Perioperative Data in Patients Undergoing Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'orgStudyIdInfo': {'id': 'YSJeon_Registry'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cardiac surgery'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Yunseok Jeon', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}