Phase 3 Study of Protective Effect of N-acetylcysteine Against From Ototoxicity
Overview
- Phase
- Phase 2
- Intervention
- N-acetylcysteine
- Conditions
- Hearing Loss, Extreme
- Sponsor
- TC Erciyes University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Threshold hearing levels
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
Peritonitis is currently one of the leading complications of continuous ambulatory peritoneal dialysis (CAPD). Aminoglycosides and vancomycin are used in the treatment of CAPD peritonitis despite their potential risk for ototoxicity. NAC is a molecule used in the treatment and prophylaxis of many diseases related to oxidative stress. The aim of this study was to examine whether ototoxicity due to antibiotics used in the treatment of CAPD peritonitis can be prevented by N-acetylcysteine
Detailed Description
NAC, a thiol-containing antioxidant because of this,we want to investigate antioxidant status.
Investigators
Ismail Kocyigit
TC Erciyes University Department of Nephrology
TC Erciyes University
Eligibility Criteria
Inclusion Criteria
- •End-stage renal disease
- •Undergoing continuous ambulatory peritoneal dialysis as a renal replacement therapy
- •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
Control
Vancomycine and/or amikacin alone
Intervention: N-acetylcysteine
N-acetylcysteine
N-acetylcysteine: Experimental N-acetylcysteine 600 mg twice daily + vancomycine and/or amikacin
Intervention: N-acetylcysteine
Outcomes
Primary Outcomes
Threshold hearing levels
Time Frame: 4 weeks
Ototoxicity was defined as an increase in the auditory threshold by at least 20 dB at any one test frequency, or at least 10 dB at any two adjacent frequencies, or loss of response at three consecutive frequencies between the baseline and follow-up studies in the worse ear.