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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01131468
First Posted: May 27, 2010
Last Update Posted: May 27, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
TC Erciyes University
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: May 17, 2010
First Posted: May 27, 2010
Last Update Posted: May 27, 2010
Last Verified: March 2010

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

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


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