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

Phase 2

Completed

• Conditions: Drug-induced Ototoxicity in Peritoneal Dialysis Patients
• Interventions: Drug: N-acetylcysteine

• Registration Number: NCT01131468
• Lead Sponsor: TC Erciyes University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Status Verified: 2010-03
• Primary Completion: 2010-04
• Study Completion: 2010-05
• Study First Submitted: 2010-05-17
• Study First Submitted QC: 2010-05-26
• Last Update Submitted: 2010-05-26
• Study First Posted: 2010-05-27
• Last Update Posted: 2010-05-27

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
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Trial Locations

Locations (1)

Erciyes University School of Medicine Department of Nephrology; 🇹🇷 Kayseri, Turkey