Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2026-03-01 @ 6:00 AM
Study NCT ID:
NCT01597102
Status:
UNKNOWN
Last Update Posted:
2020-06-11
First Post:
2012-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cerebrovascular Autoregulation During and After Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006501', 'term': 'Hepatic Encephalopathy'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D017093', 'term': 'Liver Failure'}], 'ancestors': [{'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D001928', 'term': 'Brain Diseases, Metabolic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2021-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-09', 'studyFirstSubmitDate': '2012-05-07', 'studyFirstSubmitQcDate': '2012-05-09', 'lastUpdatePostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-05-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of cerebrovascular autoregulation during liver transplantation', 'timeFrame': 'During the surgery', 'description': 'Measuring cerebrovascular autoregulation during the whole liver transplantation and compare the index of AR at the beginning with index of AR Mx after reperfusion of the transplantated liver'}], 'secondaryOutcomes': [{'measure': 'Time course of cerebrovascular autoregulation after liver transplantation', 'timeFrame': 'First 4 days after transplantation', 'description': 'Meaurement of cerebrovascular autoregulation daily for the first 4 days and calculating a time course'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['encephalopathy, hepatic', 'autoregulation, cerebrovascular', 'liver failure', 'liver transplantation'], 'conditions': ['Encephalopathy, Hepatic', 'Cerebrovascular Disorders', 'Liver Failure']}, 'descriptionModule': {'briefSummary': 'The cerebrovascular autoregulation (AR) is impaired in patients with hepatic encephalopathy. Patients with the indication to liver transplantation mostly have mild to severe hepatic encephalopathy. Transplantation should recover the encephalopathy. The aim of the study is to investigate the AR during liver transplantation, with the questions if the AR is impaired at the beginning of surgery and if there are changes in AR. For follow up the AR will be measured at the first days after transplantation at the ICU.', 'detailedDescription': 'The cerebrovascular autoregulation (AR) will be measured using transcranial doppler and calculating the index of autoregulation Mx. This measurement is continuous with online calculation. So, the possible changes over the whole time of surgery can be detected. Furthermore, the measurement of AR at the ICU will be performed daily at the same time over a measurement period of 60 Minutes and the time course of AR after liver transplantation will be described.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with and stage liver failure and transplantation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* liver transplantation\n* age \\> 18 years\n\nExclusion Criteria:\n\n* sepsis\n* preexisting cerebral diseases\n* traumatic brain injury\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT01597102', 'acronym': 'dARICULtx', 'briefTitle': 'Cerebrovascular Autoregulation During and After Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Johannes Gutenberg University Mainz'}, 'officialTitle': 'Cerebrovascular Autoregulation During and After Liver Transplantation', 'orgStudyIdInfo': {'id': '837.041.10 III'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Liver transplantation', 'description': 'Patients with liver failure and liver transplantation', 'interventionNames': ['Other: No interventions']}], 'interventions': [{'name': 'No interventions', 'type': 'OTHER', 'otherNames': ['No intervention is planned in this study'], 'description': 'No intervention is planned in this study', 'armGroupLabels': ['Liver transplantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55131', 'city': 'Mainz', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Patrick Schramm, MD', 'role': 'CONTACT', 'email': 'schrammp@uni-mainz.de', 'phone': '00496131176755'}, {'name': 'Patrick Schramm, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Medical Center', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}], 'centralContacts': [{'name': 'Patrick Schramm, MD', 'role': 'CONTACT', 'email': 'schrammp@uni-mainz.de', 'phone': '00496131176755'}], 'overallOfficials': [{'name': 'Patrick Schramm, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johannes Gutenberg University Mainz'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johannes Gutenberg University Mainz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Patrick Schramm', 'investigatorAffiliation': 'Johannes Gutenberg University Mainz'}}}}