Protective Effect of N-acetylcysteine Against From Ototoxicity

Study Overview
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Brief Summary
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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
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NAC, a thiol-containing antioxidant because of this,we want to investigate antioxidant status.

Official Title
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Phase 3 Study of Protective Effect of N-acetylcysteine Against From Ototoxicity

Conditions
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Hearing Loss, Extreme

Intervention / Treatment
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* Drug: N-acetylcysteine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: N-acetylcysteine<br>N-acetylcysteine: Experimental N-acetylcysteine 600 mg twice daily + vancomycine and/or amikacin | Drug: N-acetylcysteine<br>* N-acetylcysteine 600 mg twice a day,one week after administration of antibiotics<br>* Other names: NAC;|
| No Intervention: Control<br>Vancomycine and/or amikacin alone | Drug: N-acetylcysteine<br>* N-acetylcysteine 600 mg twice a day,one week after administration of antibiotics<br>* Other names: NAC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Threshold hearing levels | 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. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ototoxicity, aminoglycoside, vancomycine, peritoneal dialysis, peritonitis