Protective Effect of N-acetylcysteine Against From Ototoxicity

Phase 2

Completed

• Conditions: Hearing Loss, Extreme
• Interventions: Drug: N-acetylcysteine

• Registration Number: NCT01271088
• Lead Sponsor: TC Erciyes University

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.

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2011-01-05
• Study First Submitted QC: 2011-01-05
• Study First Posted: 2011-01-06
• Status Verified: 2011-11
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Last Update Submitted: 2011-11-15
• Last Update Posted: 2011-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
N-acetylcysteine	N-acetylcysteine	N-acetylcysteine: Experimental N-acetylcysteine 600 mg twice daily + vancomycine and/or amikacin
Control	N-acetylcysteine	Vancomycine and/or amikacin alone

Primary Outcome Measures

Name	Time	Method
Threshold hearing levels	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.

Trial Locations

Locations (1)

Erciyes University; 🇹🇷 Kayseri, Turkey