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

TC Erciyes University

Status and phase: Completed; Phase 2

Conditions: Drug-induced Ototoxicity in Peritoneal Dialysis Patients

Treatments: Drug: N-acetylcysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT01131468

OTOTOXICITY RESEARCH IN PD

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

N-acetylcysteine

Experimental group

Description:

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

Treatment:

Drug: N-acetylcysteine

Controls

No Intervention group

Description:

Vancomycine and/or amikacin alone

Treatment:

Drug: N-acetylcysteine