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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2010-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Drug-induced Ototoxicity in Peritoneal Dialysis Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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N-acetylcysteine

N-acetylcysteine 600 mg twice daily + vancomycine and/or amikacin

Group Type EXPERIMENTAL

N-acetylcysteine

Intervention Type DRUG

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

Controls

Vancomycine and/or amikacin alone

Group Type NO_INTERVENTION

N-acetylcysteine

Intervention Type DRUG

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

Interventions

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N-acetylcysteine

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No