Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2025-12-25 @ 3:03 PM
Study NCT ID:
NCT01022450
Status:
UNKNOWN
Last Update Posted:
2009-12-01
First Post:
2009-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Causes of the Breakdown of Muscle Fibers in Hospitalized Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012206', 'term': 'Rhabdomyolysis'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D009459', 'term': 'Neuroleptic Malignant Syndrome'}], 'ancestors': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D020258', 'term': 'Neurotoxicity Syndromes'}, {'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'lastUpdateSubmitDate': '2009-11-30', 'studyFirstSubmitDate': '2009-11-25', 'studyFirstSubmitQcDate': '2009-11-30', 'lastUpdatePostDateStruct': {'date': '2009-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['rhabdomyolysis', 'myopathy', 'acute renal failure', 'neuroleptic malignant syndrome', 'Pharmaceutical Preparations', 'Hydroxymethylglutaryl-CoA Reductase Inhibitors', 'fibrates', 'creatine kinase'], 'conditions': ['Rhabdomyolysis', 'Myopathy', 'Acute Renal Failure', 'Neuroleptic Malignant Syndrome']}, 'descriptionModule': {'briefSummary': '1. Analyze the various causes of breakdown of muscle fibers in hospitalized patients.\n2. Analyze the characteristics of these patients in Taiwan (including the drugs history, risk factors and the incidence of complications).', 'detailedDescription': '1. Find the causes of breakdown of muscle fibers in hospitalized patients through medical record review.\n\n * especially drug-related\n2. Find the risk factors of muscle fibers breakdown.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who admitted to The National Taiwan University Hospital during 2003/1/1\\~2008/12/31 with rhabdomyolysis or related muscle diseases dignosis and clinical presentation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who admitted to The National Taiwan University Hospital during 2003/1/1\\~2008/12/31 with the following discharge diagnosis: myoglobinuria, rhabdomyolysis, myopathy, toxic myopathy, malignant hyperthermia, neuroleptic malignant syndrome, polymyositis, myalgia and had acute neuromuscular illness presentations and serum creatinine kinase (CK) more than 5 times the upper limit of normal (male \\> 900 IU/L; female \\> 835 IU/L).\n\nExclusion Criteria:\n\n* Patients with recent myocardial infarction or stroke, unless clinical history, examination, or electromyography showed a concomitant myopathy.'}, 'identificationModule': {'nctId': 'NCT01022450', 'briefTitle': 'Study of the Causes of the Breakdown of Muscle Fibers in Hospitalized Patients', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Rhabdomyolysis - A Retrospective Study in Hospitalized Patients', 'orgStudyIdInfo': {'id': '200911033R'}}, 'contactsLocationsModule': {'locations': [{'zip': '10051', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Kwan-Dun Wu, MD, PhD', 'role': 'CONTACT', 'email': 'kdwu@ntuh.gov.tw', 'phone': '886-2-23123456', 'phoneExt': '65014'}, {'name': 'Fe-Lin L Wu, MSCP, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Kwan-Dun Wu, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Fe-Lin L Wu, MSCP, PhD', 'role': 'CONTACT', 'email': 'flwu@ntu.edu.tw', 'phone': '+886-2-23123456', 'phoneExt': '88389'}, {'name': 'Kwan-Dun Wu, MD, PhD', 'role': 'CONTACT', 'email': 'kdwu@ntuh.gov.tw', 'phone': '+886-2-23123456', 'phoneExt': '65014'}], 'overallOfficials': [{'name': 'Fe-Lin L Wu, MSCP, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Graduate Institute of Clinical Pharmacy, National Taiwan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Fe-Lin Lin Wu / Associate Professor, Director', 'oldOrganization': 'Graduate Institute of Clinical Pharmacy, College of Medicine, National Taiwan University'}}}}