Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-02-23 @ 4:30 AM
Study NCT ID:
NCT00243958
Status:
UNKNOWN
Last Update Posted:
2005-10-25
First Post:
2005-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aluminum and Auditory Function in ESRD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-10', 'lastUpdateSubmitDate': '2005-10-23', 'studyFirstSubmitDate': '2005-10-23', 'studyFirstSubmitQcDate': '2005-10-23', 'lastUpdatePostDateStruct': {'date': '2005-10-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-25', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['End-Stage Renal Disease (ESRD)']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nESRD 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\n\nExclusion Criteria:\n\nUnsuitable 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'}, 'identificationModule': {'nctId': 'NCT00243958', 'briefTitle': 'Aluminum and Auditory Function in ESRD', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'orgStudyIdInfo': {'id': '9461701003'}}, 'contactsLocationsModule': {'locations': [{'city': 'Douliu', 'state': 'Yun-Lin', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Pei-Lun Chu, MD, MMS', 'role': 'CONTACT', 'email': 'plchu@ha.mc.ntu.edu.tw', 'phone': '886-5-5320409', 'phoneExt': '5775'}, {'name': 'Pei-Lun Chu, MD, MMS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Taiwan University Hospital, Yun-Lin Branch', 'geoPoint': {'lat': 23.70944, 'lon': 120.54333}}, {'city': 'Douliu', 'state': 'Yun-Lin', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Pei-Lun Chu, MD, MMS', 'role': 'CONTACT', 'email': 'plchu@ha.mc.ntu.edu.tw', 'phone': '886-5-5320409', 'phoneExt': '5755'}], 'facility': 'National Taiwan University Hospital, Yun-Lin Branch', 'geoPoint': {'lat': 23.70944, 'lon': 120.54333}}], 'centralContacts': [{'name': 'Pei-Lun Chu, MD,MMS', 'role': 'CONTACT', 'email': 'plchu@ha.mc.ntu.edu.tw', 'phone': '886-5-5320409', 'phoneExt': '5755'}], 'overallOfficials': [{'name': 'Kwan-Dun Wu, MD. PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}}}}