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Incidence of Rhabdomyolysis Among Patients Admitted With Jimsonweed Ingestions

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ClinicalTrials.gov Identifier: NCT00592657
Recruitment Status : Completed
First Posted : January 14, 2008
Last Update Posted : July 28, 2008
Sponsor:
Information provided by:
Akron Children's Hospital

Study Description
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Brief Summary:
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.

Condition or disease
Rhabdomyolysis Myoglobinuria Hemoglobinuria

Study Design
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Study Type : Observational
Actual Enrollment : 46 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Incidence of Rhabdomyolysis Among Pediatric and Adolescent Patients Admitted for Jimsonweed (Datura Stramonium) Ingestions
Study Start Date : January 2008
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

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Groups and Cohorts
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Group/Cohort
1
Patients diagnosed with rhabdomyolysis and no history of jimsonweed ingestion
2
Patients diagnosed with rhabdomyolysis and history of jimsonweed ingestion


Outcome Measures
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Primary Outcome Measures :
  1. The presence of rhabdomyolysis based on serum CK concentrations in patients admitted with history of Jimsonweed ingestion. [ Time Frame: From admission until discharge ]

Secondary Outcome Measures :
  1. Renal function, liver function, vital signs, physical exam [ Time Frame: From admission until discharge ]

Eligibility Criteria
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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with rhabdomyolysis/ myoglobinuria/ hemoglobinuria (in-patient, out-patient, ER visit) at a CHMCA facility
Criteria

Inclusion Criteria:

  • 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
  • between the ages of 0-21 years at diagnosis

Exclusion Criteria:

  • rhabdomyolysis or serum CK concentrations not actually documented
  • patient admitted to the burn center
  • patient > 21 years of age
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00592657


Locations
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United States, Ohio
Children's Hospital Medical Center of Akron
Akron, Ohio, United States, 44308
Sponsors and Collaborators
Akron Children's Hospital
Investigators
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Principal Investigator: Martha Blackford CHMCA
More Information
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Publications:

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Responsible Party: Martha Blackford PharmD, CHMCA
ClinicalTrials.gov Identifier: NCT00592657    
Other Study ID Numbers: JIMSONWEED
First Posted: January 14, 2008    Key Record Dates
Last Update Posted: July 28, 2008
Last Verified: July 2008
Keywords provided by Akron Children's Hospital:
retrospective chart review
Jimsonweed ingestion
Additional relevant MeSH terms:
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Rhabdomyolysis
Myoglobinuria
Hemoglobinuria
Proteinuria
Urination Disorders
 Urologic Diseases
Urological Manifestations
Muscular Diseases
Musculoskeletal Diseases