RhabdomyolysisNCT01022450
Study of the Causes of the Breakdown of Muscle Fibers in Hospitalized Patients
An observational study of Rhabdomyolysis and Myopathy, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
1. Analyze the various causes of breakdown of muscle fibers in hospitalized patients. 2. Analyze the characteristics of these patients in Taiwan (including the drugs history, risk factors and the incidence of complications). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rhabdomyolysis, Myopathy, Acute Renal Failure
- How many people
- 2,500 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2009to Nov 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who admitted to The National Taiwan University Hospital during 2003/1/1~2008/12/31 with rhabdomyolysis or related muscle diseases dignosis and clinical presentation.
Who may be able to join
- Patients who admitted to The National Taiwan University Hospital during 2003/1/1~2008/12/31 with the following discharge diagnosis: myoglobinuria, rhabdomyolysis, myopathy, toxic myopathy, malignant hyperthermia, neuroleptic malignant syndrome, polymyositis, myalgia and had acute neuromuscular illness presentations and serum creatinine kinase (CK) more than 5 times the upper limit of normal (male > 900 IU/L; female > 835 IU/L).
Who cannot join
- Patients with recent myocardial infarction or stroke, unless clinical history, examination, or electromyography showed a concomitant myopathy.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 10051
Kwan-Dun Wu, MD, PhD, 886-2-23123456 ext. 65014, kdwu@ntuh.gov.tw
Fe-Lin L Wu, MSCP, PhD
About this study
Official title: Rhabdomyolysis - A Retrospective Study in Hospitalized Patients
- Analyze the various causes of breakdown of muscle fibers in hospitalized patients.
- Analyze the characteristics of these patients in Taiwan (including the drugs history, risk factors and the incidence of complications).
Read the detailed description
- Find the causes of breakdown of muscle fibers in hospitalized patients through medical record review.
- especially drug-related
- Find the risk factors of muscle fibers breakdown.
- Keywords
- rhabdomyolysis, myopathy, acute renal failure, neuroleptic malignant syndrome, Pharmaceutical Preparations, Hydroxymethylglutaryl-CoA Reductase Inhibitors, fibrates, creatine kinase
- Medical subject headings
- Rhabdomyolysis, Muscular Diseases, Acute Kidney Injury, Neuroleptic Malignant Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionNov 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhabdomyolysisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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 only
- Time perspective
- Retrospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Fe-Lin L Wu, MSCP, PhD, Principal investigator, Graduate Institute of Clinical Pharmacy, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01022450
- Sponsor's protocol ID
- 200911033R
- Status last verified
- Nov 2009
- First submitted
- 25 Nov 2009
- Last updated
- 1 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rhabdomyolysis - A Retrospective Study in Hospitalized Patients
- ClinicalTrials.gov ID
- NCT01022450
- Acronym / sponsor ID
- 200911033R
- Keywords
- rhabdomyolysis, myopathy, acute renal failure, neuroleptic malignant syndrome, Pharmaceutical Preparations, Hydroxymethylglutaryl-CoA Reductase Inhibitors, fibrates, creatine kinase
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Nov 2010 (estimated)
- First posted
- 1 Dec 2009 (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.
- Analyze the various causes of breakdown of muscle fibers in hospitalized patients.
- Analyze the characteristics of these patients in Taiwan (including the drugs history, risk factors and the incidence of complications).
Detailed description
- Find the causes of breakdown of muscle fibers in hospitalized patients through medical record review.
- especially drug-related
- Find the risk factors of muscle fibers breakdown.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who admitted to The National Taiwan University Hospital during 2003/1/1~2008/12/31 with rhabdomyolysis or related muscle diseases dignosis and clinical presentation.
Key inclusion criteria (1 listed)
- Patients who admitted to The National Taiwan University Hospital during 2003/1/1~2008/12/31 with the following discharge diagnosis: myoglobinuria, rhabdomyolysis, myopathy, toxic myopathy, malignant hyperthermia, neuroleptic malignant syndrome, polymyositis, myalgia and had acute neuromuscular illness presentations and serum creatinine kinase (CK) more than 5 times the upper limit of normal (male > 900 IU/L; female > 835 IU/L).
Key exclusion criteria (1 listed)
- Patients with recent myocardial infarction or stroke, unless clinical history, examination, or electromyography showed a concomitant myopathy.
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2009.
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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.
Fe-Lin L Wu, MSCP, PhD principal investigator
Graduate Institute of Clinical Pharmacy, National Taiwan University
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 Myopathy, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 1 Dec 2009. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fe-Lin L Wu, MSCP, PhD (+886-2-23123456 ext. 88389, flwu@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 1 Dec 2009.