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Incidence of Rhabdomyolysis Among Patients Admitted With Jimsonweed Ingestions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00592657
First Posted: January 14, 2008
Last Update Posted: July 28, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Akron Children's Hospital
  Purpose
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
Rhabdomyolysis Myoglobinuria Hemoglobinuria

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Incidence of Rhabdomyolysis Among Pediatric and Adolescent Patients Admitted for Jimsonweed (Datura Stramonium) Ingestions

Resource links provided by NLM:


Further study details as provided by Akron Children's Hospital:

Primary Outcome Measures:
  • 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:
  • Renal function, liver function, vital signs, physical exam [ Time Frame: From admission until discharge ]

Enrollment: 46
Study Start Date: January 2008
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients diagnosed with rhabdomyolysis and no history of jimsonweed ingestion
2
Patients diagnosed with rhabdomyolysis and history of jimsonweed ingestion

  Eligibility

Information from the National Library of Medicine

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

Publications:
Responsible Party: Martha Blackford PharmD, CHMCA
ClinicalTrials.gov Identifier: NCT00592657     History of Changes
Other Study ID Numbers: JIMSONWEED
First Submitted: January 1, 2008
First Posted: January 14, 2008
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:
Hemoglobinuria
Rhabdomyolysis
Myoglobinuria
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases