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Aluminum and Auditory Function in ESRD

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT00243958
Collaborator
(none)
80
Enrollment
2
Locations
40
Patients Per Site

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Observational Model:
    Case-Control
    Time Perspective:
    Other
    Study Start Date :
    Oct 1, 2005

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      20 Years to 75 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      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

      Locations

      Site City State Country Postal Code
      1 National Taiwan University Hospital, Yun-Lin Branch Dou-Liu Yun-Lin Taiwan
      2 National Taiwan University Hospital, Yun-Lin Branch Dou-Liu Yun-Lin Taiwan

      Sponsors and Collaborators

      • National Taiwan University Hospital

      Investigators

      • Study Chair: Kwan-Dun Wu, MD. PhD, National Taiwan University Hospital

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00243958
      Other Study ID Numbers:
      • 9461701003
      First Posted:
      Oct 25, 2005
      Last Update Posted:
      Oct 25, 2005
      Last Verified:
      Oct 1, 2005
      Additional relevant MeSH terms:
      Kidney Failure, Chronic

      Study Results

      No Results Posted as of Oct 25, 2005