Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-25 @ 5:30 PM
Study NCT ID:
NCT01516359
Status:
UNKNOWN
Last Update Posted:
2012-01-24
First Post:
2012-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incidence and Predictive Factors of Intestinal Injury in Patients Undergoing Heart Valve Replacements
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples are retained for the detections of some biomarkers and gene polymorphism.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2012-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-01-19', 'studyFirstSubmitDate': '2012-01-16', 'studyFirstSubmitQcDate': '2012-01-19', 'lastUpdatePostDateStruct': {'date': '2012-01-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'score of gut dysfunction', 'timeFrame': 'eight months', 'description': 'At different time points, gut dysfunction is graded according to previous criterion.'}], 'secondaryOutcomes': [{'measure': 'The duration of cardiopulmonary bypass', 'timeFrame': 'Eight months', 'description': 'Record the duration of cardiopulmonary bypass'}, {'measure': 'The duration for aortic artery clamping', 'timeFrame': 'eight months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Injury of Other and Multiple Parts of Small Intestine']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the incidence and predictive factors related to intestinal injury in patients undergoing heart valve replacement through a multicenter study in China.', 'detailedDescription': 'Intestinal injury is one of main reasons for mobidity and mortality after heart valve replacement, but its incidence and potential risk factors remain unclear. A multicenter study in China is undertaken to investigate the incidence and predictive factors related to intestinal injury in patients undergoing heart valve replacement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '16 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing heart valve replacements under cardiopulmonary bypass', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing heart valve replacements under cardiopulmonary bypass\n\nExclusion Criteria:\n\n* Patients who die during or after operation'}, 'identificationModule': {'nctId': 'NCT01516359', 'briefTitle': 'Incidence and Predictive Factors of Intestinal Injury in Patients Undergoing Heart Valve Replacements', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital, Sun Yat-Sen University'}, 'officialTitle': 'Official Title is Required by the WHO and ICMJE', 'orgStudyIdInfo': {'id': 'intestinal injury'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with cardiac surgery'}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ke Xuan Liu, MD, Ph.D.', 'role': 'CONTACT', 'email': 'liukexuan807@yahoo.com.cn', 'phone': '86-13710684096'}, {'name': 'Cai Li, MD', 'role': 'CONTACT', 'email': 'licaigz@yahoo.com.cn', 'phone': '86-18602017796'}, {'name': 'Ke Xuan Liu, MD, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Ke Xuan Liu, MD,Ph.D.', 'role': 'CONTACT', 'email': 'liukexuan807@yahoo.com.cn', 'phone': '86-20-87755766', 'phoneExt': '8273'}], 'overallOfficials': [{'name': 'Ke Xuan Liu, MD, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Affiliated Hospital, Sun Yat-Sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cai Li', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Vice head of Dept. of Anesthesiology', 'investigatorFullName': 'Cai Li', 'investigatorAffiliation': 'First Affiliated Hospital, Sun Yat-Sen University'}}}}