Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-02-13 @ 3:38 PM
Study NCT ID:
NCT06215404
Status:
RECRUITING
Last Update Posted:
2025-04-11
First Post:
2024-01-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluid Management Strategies on Blood Loss in Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-08', 'studyFirstSubmitDate': '2024-01-10', 'studyFirstSubmitQcDate': '2024-01-10', 'lastUpdatePostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'blood loss intraoperatively', 'timeFrame': 'during the operation', 'description': 'blood loss intraoperatively in liver transplant'}], 'secondaryOutcomes': [{'measure': 'Lung injury biomarker', 'timeFrame': 'from biginning of the operation to postoprative day 1', 'description': 'serum Clara Cell Protein (CC16)'}, {'measure': 'Kidney injury biomarker', 'timeFrame': 'from biginning of the operation to postoprative day 1', 'description': 'serum Neutrophil Gelatinase Associated Lipocalins (NGALs)'}, {'measure': 'Influammatory reponses', 'timeFrame': 'from biginning of the operation to postoprative day 1', 'description': 'IL-6'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fluid management', 'blood loss'], 'conditions': ['Liver Transplant']}, 'descriptionModule': {'briefSummary': 'During liver transplantation, due to the complexity of the operation and abnormal coagulation function, there may be a large amount of bleeding and corresponding blood transfusion. Excessive blood transfusion will increase pulmonary complications and affect the prognosis. Infusion management to reduce bleeding is a very important issue in liver transplant surgery. Restrictive infusion management can effectively reduce the amount of bleeding in liver transplantation, but it remains unclear whether it will cause sequelae in other major organs.\n\nThe investigators plan to study different infusion goals and strategies in liver transplant surgery using a randomized group model, using the PiCCO (Pulse Contour Cardiac Output) cardiopulmonary volume monitor, and setting the stroke volume variation (SVV) as the macroscopic circulation.The purpose of this study was to divide it into restrictive and liberal groups to explore the impact on liver transplantation bleeding volume and inflammatory response as well as postoperative lung and renal function, and to collect statistics on clinical care and postoperative sequelae (pulmonary liver, renal function impairment, etc.) in order to develop the most appropriate infusion management strategy in liver transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* end stage liver disease\n* age between 18y/o to 75 y/o\n* expected to recieve to receive liver transplantation\n\nExclusion Criteria:\n\n* arrythmia'}, 'identificationModule': {'nctId': 'NCT06215404', 'briefTitle': 'Fluid Management Strategies on Blood Loss in Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Effects of Different Fluid Management Strategies on Blood Loss, Inflammatory Response, and Major Organ Sequelae in Liver Transplantation', 'orgStudyIdInfo': {'id': '202308015MINC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Liberal group', 'description': 'stroke volume variation \\< 10%', 'interventionNames': ['Other: Liberal group']}, {'type': 'EXPERIMENTAL', 'label': 'restrictive group', 'description': 'stroke volume variation \\< 18%', 'interventionNames': ['Other: restrictive group']}], 'interventions': [{'name': 'Liberal group', 'type': 'OTHER', 'description': 'Fluid challage to keep stroke volume variation \\< 10%', 'armGroupLabels': ['Liberal group']}, {'name': 'restrictive group', 'type': 'OTHER', 'description': 'Fluid challage to keep stroke volume variation \\< 18%', 'armGroupLabels': ['restrictive group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Kuang-Cheng Chan', 'role': 'CONTACT'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Kuang-Cheng Chan, M.D.,PhD.', 'role': 'CONTACT', 'email': 'jkjchan@gmail.com', 'phone': '+886-2-23123456', 'phoneExt': '262158'}], 'overallOfficials': [{'name': 'Kuang-Cheng Chan, M.D.,PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology, National Taiwan University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}