Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2025-12-26 @ 7:23 AM
Study NCT ID:
NCT00424957
Status:
COMPLETED
Last Update Posted:
2009-02-05
First Post:
2007-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brain Energy Metabolism in Patients With Chronic Liver Disease and Impaired Central Nervous System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D006501', 'term': 'Hepatic Encephalopathy'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017093', 'term': 'Liver Failure'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-04', 'studyFirstSubmitDate': '2007-01-19', 'studyFirstSubmitQcDate': '2007-01-19', 'lastUpdatePostDateStruct': {'date': '2009-02-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Ammonia', 'Astrocytes', 'Citric acid cycle', 'Alpha ketoglutarate dehydrogenase'], 'conditions': ['Cirrhosis', 'Hepatic Encephalopathy']}, 'referencesModule': {'references': [{'pmid': '15921824', 'type': 'BACKGROUND', 'citation': 'Ott P, Clemmesen O, Larsen FS. Cerebral metabolic disturbances in the brain during acute liver failure: from hyperammonemia to energy failure and proteolysis. Neurochem Int. 2005 Jul;47(1-2):13-8. doi: 10.1016/j.neuint.2005.04.002.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the current study is to look into the pathogenesis of a severe medical condition causing acute episodes on the central nervous system as seen in majority of patients with liver cirrhosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '6 patients with liver cirrhosis with an acute episode of hepatic encephalopathy, 6 patients with liver cirrhosis without an acute episode of hepatic encephalopathy, 6 healthy subjects age and sex matched', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 6 patients with liver cirrhosis with an acute episode of hepatic encephalopathy,\n* 6 patients with liver cirrhosis without an acute episode of hepatic encephalopathy,\n* 6 healthy subjects age and sex matched\n\nExclusion Criteria:\n\n* Neurological and/or psychiatric condition,\n* Non-treated diabetes,\n* Pregnancy/breast-feeding'}, 'identificationModule': {'nctId': 'NCT00424957', 'briefTitle': 'Brain Energy Metabolism in Patients With Chronic Liver Disease and Impaired Central Nervous System', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Brain Energy Metabolism in Patients With Acute Hepatic Encephalopathy Measured With PET', 'orgStudyIdInfo': {'id': '20060120'}}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'PET Centre, Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Susanne Keiding, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'PET Centre and Medical department V, Aarhus Sygehus, Aarhus University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Peter Iversen', 'oldOrganization': 'PET Center, Aarhus University Hospital'}}}}