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

This study has been completed.
Sponsor:
Information provided by:
TC Erciyes University
ClinicalTrials.gov Identifier:
NCT01131468
First received: May 17, 2010
Last updated: May 26, 2010
Last verified: March 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Drug-induced Ototoxicity in Peritoneal Dialysis Patients
 Drug: N-acetylcysteine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Evaluation of the Protective Effect of N-Acetylcysteine Against Drug Induced Ototoxicity in Peritoneal Dialysis Patients

Resource links provided by NLM:

MedlinePlus related topics: Dialysis
U.S. FDA Resources

Further study details as provided by TC Erciyes University:

Enrollment: 60
Study Start Date: February 2008
Study Completion Date: May 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: N-acetylcysteine
N-acetylcysteine 600 mg twice daily + vancomycine and/or amikacin
 Drug: N-acetylcysteine
N-acetylcysteine 600 mg twice daily or vancomycine+amikacin alone
No Intervention: Controls
Vancomycine and/or amikacin alone
 Drug: N-acetylcysteine
N-acetylcysteine 600 mg twice daily or vancomycine+amikacin alone

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01131468

Locations
Turkey
Erciyes University School of Medicine Department of Nephrology
Kayseri, Turkey, 38039
Sponsors and Collaborators
TC Erciyes University
Investigators
Principal Investigator: Bulent Tokgoz, MD Erciyes University School of Medicine
  More Information

No publications provided by TC Erciyes University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT01131468     History of Changes
Other Study ID Numbers: OTOTOXICITY RESEARCH IN PD
Study First Received: May 17, 2010
Last Updated: May 26, 2010
Health Authority: Turkey: Ethics Committee

Keywords provided by TC Erciyes University:
ototoxicity
aminoglycoside
vancomycine
peritoneal dialysis
peritonitis

Additional relevant MeSH terms:
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
 Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on May 19, 2013