Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-02-23 @ 11:35 AM
Study NCT ID:
NCT01922557
Status:
COMPLETED
Last Update Posted:
2013-08-14
First Post:
2013-07-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thoracic Fluid Content and Acute Lung Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055371', 'term': 'Acute Lung Injury'}], 'ancestors': [{'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-12', 'studyFirstSubmitDate': '2013-07-11', 'studyFirstSubmitQcDate': '2013-08-12', 'lastUpdatePostDateStruct': {'date': '2013-08-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac index', 'timeFrame': 'one day', 'description': 'Participants will be followed for the duration the operation. Cardiac index was measured by non-invasive cardiac output monitor at different time points as baseline(T1), anhepatic phase(T2), 30 mins after reperfusion(T3) and 2 hrs after reperfusion(T4)'}], 'secondaryOutcomes': [{'measure': 'Thoracic fluid content', 'timeFrame': 'one day', 'description': 'Participants will be followed for the duration the operation.Thoracic fluid content was measured in liver transplant recipients at different time points as baseline(T1), anhepatic phase(T2), 30 mins after reperfusion(T3) and 2 hrs after reperfusion(T4).'}]}, 'conditionsModule': {'conditions': ['Acute Lung Injury']}, 'referencesModule': {'references': [{'pmid': '17112879', 'type': 'BACKGROUND', 'citation': 'Hong SK, Hwang S, Lee SG, Lee LS, Ahn CS, Kim KH, Moon DB, Ha TY. Pulmonary complications following adult liver transplantation. Transplant Proc. 2006 Nov;38(9):2979-81. doi: 10.1016/j.transproceed.2006.08.090.'}]}, 'descriptionModule': {'briefSummary': 'To study the association of the thoracic fluid content and acute lung injury during liver transplantation.', 'detailedDescription': 'Acute lung injury is not uncommon after liver transplantation. A new monitor non-invasive cardiac output monitor (NICOM) is designed to measure thoracic fluid content. The investigators attempt to use the parameter thoracic fluid content to investigate its relationship with acute lung injury in liver transplant recipients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'end stage liver disease patients scheduled for liver transplantation in National Taiwan University Hospital were enrolled.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* end stage liver disease scheduled for liver transplantation in National Taiwna University Hospital.\n\nExclusion Criteria:\n\n* allergic reaction\n* history of aortic regurgitation\n* pre-existing pulmonary disease'}, 'identificationModule': {'nctId': 'NCT01922557', 'briefTitle': 'Thoracic Fluid Content and Acute Lung Injury', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'The Association of Thoracic Fluid Content and Acute Lung Injury in Liver Transplantation', 'orgStudyIdInfo': {'id': '201012081RC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'NICOM', 'interventionNames': ['Device: NICOM']}], 'interventions': [{'name': 'NICOM', 'type': 'DEVICE', 'description': 'NICOM monitoring thoracic fluid content at baseline(T1), anhepatic phase(T2), 30 mins after reperfusion(T3) and 2 hrs after reperfusion(T4).', 'armGroupLabels': ['NICOM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Department of Anesthesiology, NTUH', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Kuang Cheng Chan, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology, NTUH, Taipei, Taiwan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}