Incidence of Rhabdomyolysis Among Patients Admitted With Jimsonweed Ingestions

This study has been completed.

First Received: January 1, 2008 Last Updated: July 25, 2008 History of Changes

Sponsored by:	Akron Children's Hospital
Information provided by:	Akron Children's Hospital
ClinicalTrials.gov Identifier:	NCT00592657

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

U.S. FDA Resources

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

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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:

Forrester MB. Jimsonweed (Datura stramonium) exposures in Texas, 1998-2004. J Toxicol Environ Health A. 2006 Oct;69(19):1757-62.

Ertekin V, Selimoğlu 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. No abstract available.

Giannoglou GD, Chatzizisis YS, Misirli G. The syndrome of rhabdomyolysis: Pathophysiology and diagnosis. Eur J Intern Med. 2007 Mar;18(2):90-100.

Responsible Party:	CHMCA ( Martha Blackford PharmD )
Study ID Numbers:	JIMSONWEED
Study First Received:	January 1, 2008
Last Updated:	July 25, 2008
ClinicalTrials.gov Identifier:	NCT00592657 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Akron Children's Hospital:

retrospective chart review
Jimsonweed ingestion

Study placed in the following topic categories:

Signs and Symptoms
Hemoglobinuria
Proteinuria
Muscular Diseases
Rhabdomyolysis

Musculoskeletal Diseases
Urologic Diseases
Urination Disorders
Myoglobinuria

Additional relevant MeSH terms:

Signs and Symptoms
Urological Manifestations
Hemoglobinuria
Proteinuria
Muscular Diseases

Rhabdomyolysis
Musculoskeletal Diseases
Urologic Diseases
Urination Disorders
Myoglobinuria

ClinicalTrials.gov processed this record on May 07, 2009