Study of the Causes of the Breakdown of Muscle Fibers in... | NCT01022450

Studies
Study of the Causes of the Breakdown of Muscle Fibers in Hospitalized Patients

NCT01022450

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Dec 1, 2009Estimated

Enrollment

2,500Estimated

Phase

Not provided

Conditions

Rhabdomyolysis
Myopathy
Acute Renal Failure
Neuroleptic Malignant Syndrome

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Nov 2010Estimated

Completion Date

Not provided

First Submitted Date

Nov 25, 2009

First Submission Date that Met QC Criteria

Nov 30, 2009

First Posted Date

Dec 1, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 30, 2009

Last Update Posted Date

Dec 1, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Conditions Module

Conditions

Rhabdomyolysis
Myopathy
Acute Renal Failure
Neuroleptic Malignant Syndrome

Keywords

rhabdomyolysis
myopathy
acute renal failure
neuroleptic malignant syndrome
Pharmaceutical Preparations
Hydroxymethylglutaryl-CoA Reductase Inhibitors
fibrates
creatine kinase

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,500Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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).

Exclusion Criteria:

Patients with recent myocardial infarction or stroke, unless clinical history, examination, or electromyography showed a concomitant myopathy.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fe-Lin L Wu, MSCP, PhD	Contact	+886-2-23123456	88389	flwu@ntu.edu.tw
Kwan-Dun Wu, MD, PhD	Contact	+886-2-23123456	65014	kdwu@ntuh.gov.tw

Overall Officials

Name	Affiliation	Role
Fe-Lin L Wu, MSCP, PhD	Graduate Institute of Clinical Pharmacy, National Taiwan University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital	Recruiting	Taipei		10051	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D012206	Rhabdomyolysis
D009135	Muscular Diseases
D058186	Acute Kidney Injury
D009459	Neuroleptic Malignant Syndrome

Ancestor Terms

ID	Term
D009140	Musculoskeletal Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D051437	Renal Insufficiency

Browse Leaves

Not provided

Browse Branches

Not provided