Aluminum and Auditory Function in ESRD
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | October 23, 2005 | ||||
| Last Updated Date | October 23, 2005 | ||||
| Start Date ICMJE | October 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Aluminum and Auditory Function in ESRD | ||||
| Official Title ICMJE | Not Provided | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Primary Purpose: Screening Time Perspective: Cross-Sectional Time Perspective: Retrospective/Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Not Provided | ||||
| Study Population | Not Provided | ||||
| Condition ICMJE | End-Stage Renal Disease (ESRD) | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Enrollment ICMJE | 80 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | 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 |
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| Gender | Both | ||||
| Ages | 20 Years to 75 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Taiwan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00243958 | ||||
| Other Study ID Numbers ICMJE | 9461701003 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | National Taiwan University Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | National Taiwan University Hospital | ||||
| Verification Date | October 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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