NCT00592657

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 1, 2008

Completed
Same day until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 14, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

July 28, 2008

Status Verified

July 1, 2008

Enrollment Period

3 months

First QC Date

January 1, 2008

Last Update Submit

July 25, 2008

Conditions

Keywords

retrospective chart reviewJimsonweed ingestion

Outcome Measures

Primary Outcomes (1)

  • The presence of rhabdomyolysis based on serum CK concentrations in patients admitted with history of Jimsonweed ingestion.

    From admission until discharge

Secondary Outcomes (1)

  • Renal function, liver function, vital signs, physical exam

    From admission until discharge

Study Arms (2)

1

Patients diagnosed with rhabdomyolysis and no history of jimsonweed ingestion

2

Patients diagnosed with rhabdomyolysis and history of jimsonweed ingestion

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with rhabdomyolysis/ myoglobinuria/ hemoglobinuria (in-patient, out-patient, ER visit) at a CHMCA facility

You may qualify if:

  • 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

You may not qualify if:

  • rhabdomyolysis or serum CK concentrations not actually documented
  • patient admitted to the burn center
  • patient \> 21 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Medical Center of Akron

Akron, Ohio, 44308, United States

Location

Related Publications (3)

  • Forrester MB. Jimsonweed (Datura stramonium) exposures in Texas, 1998-2004. J Toxicol Environ Health A. 2006 Oct;69(19):1757-62. doi: 10.1080/15287390600631284.

    PMID: 16905506BACKGROUND
  • 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. doi: 10.1016/j.jemermed.2004.11.006. No abstract available.

    PMID: 15707824BACKGROUND
  • Giannoglou GD, Chatzizisis YS, Misirli G. The syndrome of rhabdomyolysis: Pathophysiology and diagnosis. Eur J Intern Med. 2007 Mar;18(2):90-100. doi: 10.1016/j.ejim.2006.09.020.

    PMID: 17338959BACKGROUND

MeSH Terms

Conditions

RhabdomyolysisMyoglobinuriaHemoglobinuria

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesProteinuriaUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Martha Blackford

    CHMCA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 1, 2008

First Posted

January 14, 2008

Study Start

January 1, 2008

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

July 28, 2008

Record last verified: 2008-07

Locations