Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-05 @ 12:31 PM
Study NCT ID:
NCT02402634
Status:
COMPLETED
Last Update Posted:
2019-02-15
First Post:
2015-03-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inflammatory Gene Polymorphism and Prolonged Mechanical Ventilation After Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 141}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-01-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-14', 'studyFirstSubmitDate': '2015-03-25', 'studyFirstSubmitQcDate': '2015-03-25', 'lastUpdatePostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'total duration of postoperative ventilator care', 'timeFrame': 'an expected average of 2-3 days', 'description': 'Time for successful weaning from ventilator could correlate with the inflammtory gene polymorphism, especially those related to acute lung injury.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Patients With Postoperative Mechanical Ventilation After Liver Transplantation']}, 'descriptionModule': {'briefSummary': 'Mechanical ventilatory lung care is essential for postoperative care in liver transplantation recipients, for such patients are under massive fluid challenge and hemodynamic alterations perioperatively. Some of the recipients experience difficulty in weaning off from the mechanical ventilator due to various causes. This study is to investigate the relationship between the inflammatory gene polymorphism, known for acute lung injury, and the duration of mechanical ventilatory care for such liver transplantation recipients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '20-65 years old, scheduled for liver transplantation.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 20-65 years old\n2. scheduled for liver transplantation\n\nExclusion Criteria:\n\n1. Patients under mechanical ventilation prior to surgery\n2. patients with muscular skeletal disorder, probable cause for respiratory depression\n3. patients not able to read, or understand the consent form\n4. ethnicity, other than asian\n5. patients refusal'}, 'identificationModule': {'nctId': 'NCT02402634', 'briefTitle': 'Inflammatory Gene Polymorphism and Prolonged Mechanical Ventilation After Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2014-0989'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mechanical ventilatory lung care', 'description': 'liver transplantation recipients under mechanical ventilatory lung care', 'interventionNames': ['Other: Mechanical ventilatory lung care']}], 'interventions': [{'name': 'Mechanical ventilatory lung care', 'type': 'OTHER', 'armGroupLabels': ['Mechanical ventilatory lung care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}