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Aluminum and Auditory Function in ESRD

This study is currently recruiting participants.
Verified by National Taiwan University Hospital, October 2005

Sponsored by: National Taiwan University Hospital
Information provided by: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00243958
  Purpose

Hearing impairment either clinical or subclinical is a characteristic of some renal disease patients. The hearing impairment could be result from specific etiologies or chronic renal failure itself. The causes of hearing impairment in renal disease patients ranged from drugs intoxication in both auditory and renal function, like gentamycin or isoniazid, congenital disease like Alport syndrome or other collagen-defective renal disease, or just aging related. End-stage renal disease (ESRD) patients are special in many parts to general population who have hearing impairment. First, inflammation in ESRD patients is well-documented, second, they suffered from various underlying diseases which auditory function was potentially impaired, third, they need to undergo renal replacement therapy either hemodialysis (HD) or peritoneal dialysis (PD) to maintain their life. Dialysis itself was found to be a cause of hearing impairment, too. The biochemical change and constitutive inflammation status are thought to be implicated in the pathogenesis of hearing impairment in ESRD patients. Aluminum (Al) is a well-documented heavy metal, which predisposes to Alzheimer’s disease, dementia or some neurologic diseases. Al intoxication is very rare in general health population but elevated serum Al level is easily found in ESRD patients since they can not excrete Al by damaged kidneys and dialyzers. Inner ear per se is a neurologic tissue, so if serum Al level in ESRD patients has any association in their haring function needs to be studied.


Condition
End-Stage Renal Disease (ESRD)

MedlinePlus related topics:   Hearing Disorders and Deafness    Kidney Failure   

ChemIDplus related topics:   Aluminum   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Screening, Cross-Sectional, Case Control, Retrospective/Prospective Study

Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment:   80
Study Start Date:   October 2005

  Eligibility
Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

ESRD patients and healthy volunteers, without history of occupational noise exposure, ear infection, ear surgery, active systemic infection, previous ototoxic drugs exposure or congenital hearing defect

Exclusion Criteria:

Unsuitable to undergo hearing test, with history of occupational noise exposure, ear infection, ear surgery, active systemic infection, previous ototoxic drugs exposure or congenital hearing defect

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00243958

Contacts
Contact: Pei-Lun Chu, MD,MMS     886-5-5320409 ext 5755     plchu@ha.mc.ntu.edu.tw    

Locations
Taiwan, Yun-Lin
National Taiwan University Hospital, Yun-Lin Branch     Recruiting
      Dou-Liu, Yun-Lin, Taiwan
      Contact: Pei-Lun Chu, MD, MMS     886-5-5320409 ext 5775     plchu@ha.mc.ntu.edu.tw    
      Principal Investigator: Pei-Lun Chu, MD, MMS            
National Taiwan University Hospital, Yun-Lin Branch     Recruiting
      Dou-Liu, Yun-Lin, Taiwan
      Contact: Pei-Lun Chu, MD, MMS     886-5-5320409 ext 5755     plchu@ha.mc.ntu.edu.tw    

Sponsors and Collaborators
National Taiwan University Hospital

Investigators
Study Chair:     Kwan-Dun Wu, MD. PhD     National Taiwan University Hospital    
  More Information


Study ID Numbers:   9461701003
First Received:   October 23, 2005
Last Updated:   October 23, 2005
ClinicalTrials.gov Identifier:   NCT00243958
Health Authority:   Taiwan: Department of Health

Study placed in the following topic categories:
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on October 09, 2008




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