Prevention of Drug Induced Ototoxicity in Peritoneal Dialysis Patients by N-Acetylcysteine

The Evaluation of the Protective Effect of N-Acetylcysteine Against Drug Induced Ototoxicity in Peritoneal Dialysis Patients

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01131468

Enrollment

Registered

2010-05-27

Start date

2008-02-29

Completion date

2010-05-31

Last updated

2010-05-27

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

Conditions

Drug-induced Ototoxicity in Peritoneal Dialysis Patients

Keywords

ototoxicity, aminoglycoside, vancomycine, peritoneal dialysis, peritonitis

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.

Interventions

DRUGN-acetylcysteine

N-acetylcysteine 600 mg twice daily or vancomycine+amikacin alone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Countries

Turkey (Türkiye)

Outcome results

None listed

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