RhabdomyolysisNCT00592657
Incidence of Rhabdomyolysis Among Patients Admitted With Jimsonweed Ingestions
An observational study of Rhabdomyolysis and Myoglobinuria, run by Akron Children's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Rhabdomyolysis, Myoglobinuria, Hemoglobinuria
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Apr 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients diagnosed with rhabdomyolysis/ myoglobinuria/ hemoglobinuria (in-patient, out-patient, ER visit) at a CHMCA facility
Who may be able to join
- 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
Who cannot join
- rhabdomyolysis or serum CK concentrations not actually documented
- patient admitted to the burn center
- patient > 21 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308
About this study
Official title: Incidence of Rhabdomyolysis Among Pediatric and Adolescent Patients Admitted for Jimsonweed (Datura Stramonium) Ingestions
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.
- Conditions
- Rhabdomyolysis, Myoglobinuria, Hemoglobinuria
- Keywords
- retrospective chart review, Jimsonweed ingestion
- Medical subject headings
- Rhabdomyolysis, Myoglobinuria, Hemoglobinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients diagnosed with rhabdomyolysis and no history of jimsonweed ingestion | |
| 2 | Patients diagnosed with rhabdomyolysis and history of jimsonweed ingestion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence of rhabdomyolysis based on serum CK concentrations in patients admitted with history of Jimsonweed ingestion.
Measured: From admission until discharge
Secondary outcomes (1)
Renal function, liver function, vital signs, physical exam
Measured: From admission until discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for RhabdomyolysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akron Children's Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Martha Blackford, Principal investigator, CHMCA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00592657
- Sponsor's protocol ID
- JIMSONWEED
- Status last verified
- Jul 2008
- First submitted
- 1 Jan 2008
- Last updated
- 28 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16905506Ertekin 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.
PubMed 15707824Giannoglou 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.
PubMed 17338959
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Rhabdomyolysis Among Pediatric and Adolescent Patients Admitted for Jimsonweed (Datura Stramonium) Ingestions
- ClinicalTrials.gov ID
- NCT00592657
- Acronym / sponsor ID
- JIMSONWEED
- Conditions
- Rhabdomyolysis, Myoglobinuria, Hemoglobinuria
- Keywords
- retrospective chart review, Jimsonweed ingestion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Akron Children's HospitalUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 14 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients diagnosed with rhabdomyolysis and no history of jimsonweed ingestion |
| 2 | – | –Patients diagnosed with rhabdomyolysis and history of jimsonweed ingestion |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients diagnosed with rhabdomyolysis/ myoglobinuria/ hemoglobinuria (in-patient, out-patient, ER visit) at a CHMCA facility
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- rhabdomyolysis or serum CK concentrations not actually documented
- patient admitted to the burn center
- patient > 21 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The presence of rhabdomyolysis based on serum CK concentrations in patients admitted with history of Jimsonweed ingestion.
Time frame: From admission until discharge
1 secondary outcome
Renal function, liver function, vital signs, physical exam
Time frame: From admission until discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2008.
- Background: PubMed 16905506Forrester MB. Jimsonweed (Datura stramonium) exposures in Texas, 1998-2004. J Toxicol Environ Health A. 2006 Oct;69(19):1757-62. doi: 10.1080/15287390600631284.
- Background: PubMed 15707824Ertekin 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.
- Background: PubMed 17338959Giannoglou 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martha Blackford principal investigator
CHMCA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhabdomyolysis and Myoglobinuria, run by Akron Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The presence of rhabdomyolysis based on serum CK concentrations in patients admitted with history of Jimsonweed ingestion. (time frame: From admission until discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00592657, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2008.