Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-01-08 @ 6:59 PM
Study NCT ID:
NCT06890234
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-03-21
First Post:
2025-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tissue Microdialysis Monitoring of Liver Grafts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Interstitial molecules in liver tissue with a molecular weight below 100 kDa'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}, 'targetDuration': '5 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-16', 'studyFirstSubmitDate': '2025-03-16', 'studyFirstSubmitQcDate': '2025-03-16', 'lastUpdatePostDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The agreement between microdialysis-derived metabolite levels and conventional liver function tests', 'timeFrame': 'From the end of liver transplant surgery up to 5 days post-transplant', 'description': 'The correlation between tissue microdialysis metabolites (glucose, pyruvate, lactate, glycerol, urea) and standard static and dynamic liver function tests (ALT, AST, bilirubin, INR, plasma lactate, plasma pyruvate, and indocyanine green \\[ICG\\] clearance) in the early post-transplant period.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['microdialysis', 'liver graft monitoring'], 'conditions': ['Liver Transplantation', 'Liver Graft Dysfunction', 'Tissue Metabolism']}, 'descriptionModule': {'briefSummary': 'This study will investigate the dynamics of metabolic molecules sampled from human liver grafts during the early postoperative period using tissue microdialysis. The obtained tissue samples will be compared with standard liver function tests and dynamic functional liver assessment tests. The primary objective is to evaluate the clinical feasibility, utility, and non-inferiority of tissue microdialysis in comparison to current standard methods for monitoring liver grafts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Liver transplant candidates satisfying the inclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Adult patients aged between 18 and 65 years.\n* Liver transplant candidates on the Slovenian liver transplant waiting list, matched with an available liver graft through the Eurotransplant system, and scheduled for the surgical procedure.\n* Signed informed consent to participate in the microdialysis sampling research project, including consent to share the obtained samples with other research studies\n\nExclusion criteria:\n\n* Patients under 18 or over 65 years of age.\n* Refusal to participate in the study.\n* Verbal withdrawal of consent at any point during the study, even if informed consent has been previously signed.\n* Surgical contraindications preventing the insertion of a microdialysis catheter into the liver graft during the procedure.\n* Surgical revision within 48 hours post-transplantation resulting in liver graft loss and removal.\n* History of allergic reactions to radiographic contrast media.\n* Death during the liver transplant procedure.'}, 'identificationModule': {'nctId': 'NCT06890234', 'briefTitle': 'Tissue Microdialysis Monitoring of Liver Grafts', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Centre Ljubljana'}, 'officialTitle': 'Clinical Applicability of Tissue Microdialysis for Early Assessment of Liver Graft Metabolism in Patients After Orthotopic Liver Transplantation', 'orgStudyIdInfo': {'id': '0120-505/2023/3'}, 'secondaryIdInfos': [{'id': 'TP20230129', 'type': 'OTHER_GRANT', 'domain': 'UMC Ljubljana'}, {'id': 'TP20240197', 'type': 'OTHER_GRANT', 'domain': 'UMC Ljubljana'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adult patients (≥18 years old) who have undergone orthotopic liver transplantation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'state': 'Slovenia', 'country': 'Slovenia', 'facility': 'University Medical Centre Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Beginning 6 months and ending 3 years after the publication of results', 'ipdSharing': 'YES', 'description': 'Raw data, with only IPD used in the results publication.', 'accessCriteria': 'A proposal describing the planned analyses must be submitted, and a data sharing agreement must be signed. Documents should be submitted via email to sergej.godec@kclj.si.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Centre Ljubljana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor, intensive care specialist', 'investigatorFullName': 'Sergej Godec', 'investigatorAffiliation': 'University Medical Centre Ljubljana'}}}}