NCT01022450

Brief Summary

  1. 1.Analyze the various causes of breakdown of muscle fibers in hospitalized patients.
  2. 2.Analyze the characteristics of these patients in Taiwan (including the drugs history, risk factors and the incidence of complications).

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
2,500

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Last Updated

December 1, 2009

Status Verified

November 1, 2009

Enrollment Period

1 year

First QC Date

November 25, 2009

Last Update Submit

November 30, 2009

Conditions

RhabdomyolysisMyopathyAcute Renal FailureNeuroleptic Malignant Syndrome

Keywords

rhabdomyolysismyopathyacute renal failureneuroleptic malignant syndromePharmaceutical PreparationsHydroxymethylglutaryl-CoA Reductase Inhibitorsfibratescreatine kinase

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 10051, Taiwan

RECRUITING

MeSH Terms

Conditions

RhabdomyolysisMuscular DiseasesAcute Kidney InjuryNeuroleptic Malignant Syndrome

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNeurotoxicity SyndromesPoisoningChemically-Induced Disorders

Study Officials

  • Fe-Lin L Wu, MSCP, PhD

    Graduate Institute of Clinical Pharmacy, National Taiwan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fe-Lin L Wu, MSCP, PhD

CONTACT

+886-2-23123456flwu@ntu.edu.tw

Kwan-Dun Wu, MD, PhD

CONTACT

+886-2-23123456kdwu@ntuh.gov.tw

Study Design

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

Study Record Dates

First Submitted

November 25, 2009

First Posted

December 1, 2009

Study Start

November 1, 2009

Primary Completion

November 1, 2010

Last Updated

December 1, 2009

Record last verified: 2009-11

Locations

TW(1)