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Incidence of Rhabdomyolysis Among Patients Admitted With Jimsonweed Ingestions

This study has been completed.
Sponsor:
Information provided by:
Akron Children's Hospital
ClinicalTrials.gov Identifier:
NCT00592657
First received: January 1, 2008
Last updated: July 25, 2008
Last verified: July 2008
History of Changes
  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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Renal function, liver function, vital signs, physical exam [ Time Frame: From admission until discharge ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: January 1, 2008
Last Updated: July 25, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Akron Children's Hospital:
retrospective chart review
Jimsonweed ingestion

Additional relevant MeSH terms:
Hemoglobinuria
Myoglobinuria
Rhabdomyolysis
Proteinuria
Urination Disorders
 Urologic Diseases
Urological Manifestations
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 23, 2013