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Aluminum and Auditory Function in ESRD

NCT ID: NCT00243958

Last Updated: 2005-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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End-Stage Renal Disease (ESRD)

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Kwan-Dun Wu, MD. PhD

Role: STUDY_CHAIR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital, Yun-Lin Branch

Douliu, Yun-Lin, Taiwan

Site Status RECRUITING

National Taiwan University Hospital, Yun-Lin Branch

Douliu, Yun-Lin, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Pei-Lun Chu, MD,MMS

Role: CONTACT

Phone: 886-5-5320409

Email: [email protected]

Facility Contacts

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Pei-Lun Chu, MD, MMS

Role: primary

Pei-Lun Chu, MD, MMS

Role: primary

Other Identifiers

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9461701003

Identifier Type: -

Identifier Source: org_study_id