NCT01131468
Completed
Phase 2
The Evaluation of the Protective Effect of N-Acetylcysteine Against Drug Induced Ototoxicity in Peritoneal Dialysis Patients
InterventionsN-acetylcysteine
DrugsN-acetylcysteine
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- TC Erciyes University
- Enrollment
- 60
- Locations
- 1
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Controls
No Intervention
Vancomycine and/or amikacin alone
Intervention: N-acetylcysteine (Drug)
N-acetylcysteine
Experimental
N-acetylcysteine 600 mg twice daily + vancomycine and/or amikacin
Intervention: N-acetylcysteine (Drug)
Investigators
Study Sites (1)
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