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Clinical Trials/NCT01131468
NCT01131468
Completed
Phase 2

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

TC Erciyes University1 site in 1 country60 target enrollmentFebruary 2008

Overview

Phase
Phase 2
Intervention
N-acetylcysteine
Conditions
Drug-induced Ototoxicity in Peritoneal Dialysis Patients
Sponsor
TC Erciyes University
Enrollment
60
Locations
1
Status
Completed
Last Updated
15 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2008
End Date
May 2010
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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

Arms & Interventions

Controls

Vancomycine and/or amikacin alone

Intervention: N-acetylcysteine

N-acetylcysteine

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

Intervention: N-acetylcysteine

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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