Incidence of Rhabdomyolysis Among Patients Admitted With Jimsonweed Ingestions

Rhabdomyolysis Clinical Trial

Official title:

Incidence of Rhabdomyolysis Among Pediatric and Adolescent Patients Admitted for Jimsonweed (Datura Stramonium) Ingestions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00592657
• Other study ID #: JIMSONWEED
• Status: Completed
• Phase: N/A
• First received: January 1, 2008
• Last updated: July 25, 2008
• Start date: January 2008
• Est. completion date: April 2008

Study information

• Verified date: July 2008
• Source: Akron Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 21 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hemoglobinuria
• Myoglobinuria
• Rhabdomyolysis

Locations

Country	Name	City	State
United States	Children's Hospital Medical Center of Akron	Akron	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Akron Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The presence of rhabdomyolysis based on serum CK concentrations in patients admitted with history of Jimsonweed ingestion.		From admission until discharge	Yes
Secondary	Renal function, liver function, vital signs, physical exam		From admission until discharge	Yes