Back to resultsPrevention of Drug Induced Ototoxicity in Peritoneal Dialysis Patients by N-Acetylcysteine
Primary Purpose
Drug-induced Ototoxicity in Peritoneal Dialysis Patients
Status
Completed
Phase
Phase 2
Locations
Turkey
Study Type
Interventional
Intervention
N-acetylcysteine
Sponsored by
About this trial
This is an interventional prevention trial for Drug-induced Ototoxicity in Peritoneal Dialysis Patients focused on measuring ototoxicity, aminoglycoside, vancomycine, peritoneal dialysis, peritonitis
Eligibility Criteria
Inclusion Criteria:
- End-stage renal disease
- Undergoing continuous ambulatory peritoneal dialysis as a renal replacement therapy
- Clinical diagnosis of a peritonitis episode in a continuous ambulatory peritoneal dialysis patient
- Developing the first continuous ambulatory peritoneal dialysis related peritonitis episode
Exclusion Criteria:
- Being treated with aminoglycoside antibiotics and vancomycine within the previous 3 months
- Detection of mechanical occlusion of external ear
- Having signs of disturbed integrity of tympanic membrane on otoscopy or tympanometry
- History of a continuous ambulatory peritoneal dialysis related peritonitis
Sites / Locations
- Erciyes University School of Medicine Department of Nephrology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
N-acetylcysteine
Controls
Arm Description
N-acetylcysteine 600 mg twice daily + vancomycine and/or amikacin
Vancomycine and/or amikacin alone
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01131468
Brief Title
Prevention of Drug Induced Ototoxicity in Peritoneal Dialysis Patients by N-Acetylcysteine
Official Title
The Evaluation of the Protective Effect of N-Acetylcysteine Against Drug Induced Ototoxicity in Peritoneal Dialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
TC Erciyes University
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug-induced Ototoxicity in Peritoneal Dialysis Patients
Keywords
ototoxicity, aminoglycoside, vancomycine, peritoneal dialysis, peritonitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
N-acetylcysteine
Arm Type
Experimental
Arm Description
N-acetylcysteine 600 mg twice daily + vancomycine and/or amikacin
Arm Title
Controls
Arm Type
No Intervention
Arm Description
Vancomycine and/or amikacin alone
Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine
Intervention Description
N-acetylcysteine 600 mg twice daily or vancomycine+amikacin alone
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
End-stage renal disease
Undergoing continuous ambulatory peritoneal dialysis as a renal replacement therapy
Clinical diagnosis of a peritonitis episode in a continuous ambulatory peritoneal dialysis patient
Developing the first continuous ambulatory peritoneal dialysis related peritonitis episode
Exclusion Criteria:
Being treated with aminoglycoside antibiotics and vancomycine within the previous 3 months
Detection of mechanical occlusion of external ear
Having signs of disturbed integrity of tympanic membrane on otoscopy or tympanometry
History of a continuous ambulatory peritoneal dialysis related peritonitis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bulent Tokgoz, MD
Organizational Affiliation
Erciyes University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erciyes University School of Medicine Department of Nephrology
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
21551083
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.
Results Reference
derived
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Prevention of Drug Induced Ototoxicity in Peritoneal Dialysis Patients by N-Acetylcysteine
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