Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-28 @ 12:06 PM
Study NCT ID:
NCT01131468
Status:
COMPLETED
Last Update Posted:
2010-05-27
First Post:
2010-05-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Drug Induced Ototoxicity in Peritoneal Dialysis Patients by N-Acetylcysteine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081015', 'term': 'Ototoxicity'}, {'id': 'D010538', 'term': 'Peritonitis'}], 'ancestors': [{'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010532', 'term': 'Peritoneal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000111', 'term': 'Acetylcysteine'}], 'ancestors': [{'id': 'D003545', 'term': 'Cysteine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-26', 'studyFirstSubmitDate': '2010-05-17', 'studyFirstSubmitQcDate': '2010-05-26', 'lastUpdatePostDateStruct': {'date': '2010-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['ototoxicity', 'aminoglycoside', 'vancomycine', 'peritoneal dialysis', 'peritonitis'], 'conditions': ['Drug-induced Ototoxicity in Peritoneal Dialysis Patients']}, 'referencesModule': {'references': [{'pmid': '21551083', 'type': 'DERIVED', 'citation': 'Tokgoz B, Ucar C, Kocyigit I, Somdas M, Unal A, Vural A, Sipahioglu M, Oymak O, Utas C. Protective effect of N-acetylcysteine from drug-induced ototoxicity in uraemic patients with CAPD peritonitis. Nephrol Dial Transplant. 2011 Dec;26(12):4073-8. doi: 10.1093/ndt/gfr211. Epub 2011 May 6.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether N-acetylcysteine is effective in the prevention of hearing loss in both ears due to aminoglycoside and/or vancomycine induced ototoxicity in peritoneal dialysis patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* End-stage renal disease\n* Undergoing continuous ambulatory peritoneal dialysis as a renal replacement therapy\n* Clinical diagnosis of a peritonitis episode in a continuous ambulatory peritoneal dialysis patient\n* Developing the first continuous ambulatory peritoneal dialysis related peritonitis episode\n\nExclusion Criteria:\n\n* Being treated with aminoglycoside antibiotics and vancomycine within the previous 3 months\n* Detection of mechanical occlusion of external ear\n* Having signs of disturbed integrity of tympanic membrane on otoscopy or tympanometry\n* History of a continuous ambulatory peritoneal dialysis related peritonitis'}, 'identificationModule': {'nctId': 'NCT01131468', 'briefTitle': 'Prevention of Drug Induced Ototoxicity in Peritoneal Dialysis Patients by N-Acetylcysteine', 'organization': {'class': 'OTHER', 'fullName': 'TC Erciyes University'}, 'officialTitle': 'The Evaluation of the Protective Effect of N-Acetylcysteine Against Drug Induced Ototoxicity in Peritoneal Dialysis Patients', 'orgStudyIdInfo': {'id': 'OTOTOXICITY RESEARCH IN PD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'N-acetylcysteine', 'description': 'N-acetylcysteine 600 mg twice daily + vancomycine and/or amikacin', 'interventionNames': ['Drug: N-acetylcysteine']}, {'type': 'NO_INTERVENTION', 'label': 'Controls', 'description': 'Vancomycine and/or amikacin alone', 'interventionNames': ['Drug: N-acetylcysteine']}], 'interventions': [{'name': 'N-acetylcysteine', 'type': 'DRUG', 'description': 'N-acetylcysteine 600 mg twice daily or vancomycine+amikacin alone', 'armGroupLabels': ['Controls', 'N-acetylcysteine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38039', 'city': 'Kayseri', 'country': 'Turkey (Türkiye)', 'facility': 'Erciyes University School of Medicine Department of Nephrology', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}], 'overallOfficials': [{'name': 'Bulent Tokgoz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erciyes University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TC Erciyes University', 'class': 'OTHER'}}}}