Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-25 @ 7:08 PM
Study NCT ID:
NCT03563404
Status:
COMPLETED
Last Update Posted:
2018-07-03
First Post:
2016-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Portal Blood Flushes in the Peri-Reperfusion Stage of Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008107', 'term': 'Liver Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-29'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2016-06-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-02', 'studyFirstSubmitDate': '2016-05-03', 'studyFirstSubmitQcDate': '2018-06-19', 'lastUpdatePostDateStruct': {'date': '2018-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemodynamic Stability', 'timeFrame': '5 days', 'description': 'The primary objective of this study is to determine whether or not a portal blood flush is useful for maintaining hemodynamic stability in the peri-reperfusion stage of Orthotopic Liver Transplantation as evidence by TEE.'}], 'secondaryOutcomes': [{'measure': 'correlation between the cardiac dysfunction and the degree of hyperkalemia seen after reperfusion.', 'timeFrame': '5 days', 'description': 'The secondary objective is to determine if there is a correlation between cardiac dysfunction as measured by a qualitative analysis of TEE and the degree of hyperkalemia measured by a post reperfusion blood sample.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Liver Disease']}, 'descriptionModule': {'briefSummary': 'By showing that increased levels of acidotic metabolites and electrolytes in the systemic blood of patients who do not receive portal blood flush prior to reperfusion compared to patients who do receive portal blood flush, and that these increased levels correlate with cardiac depression as seen on TEE, the investigators hope to find a superior technique for liver reperfusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Liver Transplant', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Liver Transplantation\n* 18 years old or older\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT03563404', 'briefTitle': 'Portal Blood Flushes in the Peri-Reperfusion Stage of Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'Are Portal Blood Flushes Useful in Maintaining Hemodynamic Stability in the Peri-Reperfusion Stage of Orthotopic Liver Transplantation', 'orgStudyIdInfo': {'id': 'Pro00044952'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Portal Blood Flush', 'description': 'participants that receive the portal blood flush'}, {'label': 'No Portal Blood Flush', 'description': "participants that don't receive the portal blood flush"}]}, 'contactsLocationsModule': {'locations': [{'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'overallOfficials': [{'name': 'Grayce Davis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}