Protective Effect of N-acetylcysteine Against From Ototoxicity

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01271088

Enrollment

Registered

2011-01-06

Start date

2010-06-30

Completion date

2011-11-30

Last updated

2011-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss, Extreme

Keywords

ototoxicity, aminoglycoside, vancomycine, peritoneal dialysis, peritonitis

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.

Interventions

DRUGN-acetylcysteine

N-acetylcysteine 600 mg twice a day,one week after administration of antibiotics

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026