Ignite Creation Date:
2025-12-24 @ 6:39 PM
Ignite Modification Date:
2026-02-19 @ 1:53 AM
Study NCT ID:
NCT00592657
Status:
COMPLETED
Last Update Posted:
2008-07-28
First Post:
2008-01-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incidence of Rhabdomyolysis Among Patients Admitted With Jimsonweed Ingestions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012206', 'term': 'Rhabdomyolysis'}, {'id': 'D009212', 'term': 'Myoglobinuria'}, {'id': 'D006456', 'term': 'Hemoglobinuria'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D011507', 'term': 'Proteinuria'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'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': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-07', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-07-25', 'studyFirstSubmitDate': '2008-01-01', 'studyFirstSubmitQcDate': '2008-01-11', 'lastUpdatePostDateStruct': {'date': '2008-07-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The presence of rhabdomyolysis based on serum CK concentrations in patients admitted with history of Jimsonweed ingestion.', 'timeFrame': 'From admission until discharge'}], 'secondaryOutcomes': [{'measure': 'Renal function, liver function, vital signs, physical exam', 'timeFrame': 'From admission until discharge'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['retrospective chart review', 'Jimsonweed ingestion'], 'conditions': ['Rhabdomyolysis', 'Myoglobinuria', 'Hemoglobinuria']}, 'referencesModule': {'references': [{'pmid': '16905506', 'type': 'BACKGROUND', 'citation': 'Forrester MB. Jimsonweed (Datura stramonium) exposures in Texas, 1998-2004. J Toxicol Environ Health A. 2006 Oct;69(19):1757-62. doi: 10.1080/15287390600631284.'}, {'pmid': '15707824', 'type': 'BACKGROUND', 'citation': 'Ertekin V, Selimoglu MA, Altinkaynak S. A combination of unusual presentations of Datura stramonium intoxication in a child: rhabdomyolysis and fulminant hepatitius. J Emerg Med. 2005 Feb;28(2):227-8. doi: 10.1016/j.jemermed.2004.11.006. No abstract available.'}, {'pmid': '17338959', 'type': 'BACKGROUND', 'citation': 'Giannoglou GD, Chatzizisis YS, Misirli G. The syndrome of rhabdomyolysis: Pathophysiology and diagnosis. Eur J Intern Med. 2007 Mar;18(2):90-100. doi: 10.1016/j.ejim.2006.09.020.'}]}, 'descriptionModule': {'briefSummary': 'Retrospective chart review to determine the presence of rhabdomyolysis among patients admitted to CHMCA from 1997-2007 with Jimsonweed ingestions and to define possible risk factors predisposing patients to the developement of Jimsonweed-associated rhabdomyolysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with rhabdomyolysis/ myoglobinuria/ hemoglobinuria (in-patient, out-patient, ER visit) at a CHMCA facility', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* admitted to CHMCA between 1/1/1997 to 12/31/2007 with a qualifying ICD-9 diagnosis code for rhabdomyolysis, myoglobinuria, and hemoglobinuria (728.88, 791.2, 791.3)or other ICD-9 codes identified during the study\n* between the ages of 0-21 years at diagnosis\n\nExclusion Criteria:\n\n* rhabdomyolysis or serum CK concentrations not actually documented\n* patient admitted to the burn center\n* patient \\> 21 years of age'}, 'identificationModule': {'nctId': 'NCT00592657', 'briefTitle': 'Incidence of Rhabdomyolysis Among Patients Admitted With Jimsonweed Ingestions', 'organization': {'class': 'OTHER', 'fullName': "Akron Children's Hospital"}, 'officialTitle': 'Incidence of Rhabdomyolysis Among Pediatric and Adolescent Patients Admitted for Jimsonweed (Datura Stramonium) Ingestions', 'orgStudyIdInfo': {'id': 'JIMSONWEED'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Patients diagnosed with rhabdomyolysis and no history of jimsonweed ingestion'}, {'label': '2', 'description': 'Patients diagnosed with rhabdomyolysis and history of jimsonweed ingestion'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44308', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': "Children's Hospital Medical Center of Akron", 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}], 'overallOfficials': [{'name': 'Martha Blackford', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHMCA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Akron Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Martha Blackford PharmD', 'oldOrganization': 'CHMCA'}}}}