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

May 26, 2010 updated by: TC Erciyes University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kayseri, Turkey, 38039
        • Erciyes University School of Medicine Department of Nephrology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TC Erciyes University

Investigators

  • Principal Investigator: Bulent Tokgoz, MD, Erciyes University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

May 17, 2010

First Submitted That Met QC Criteria

May 26, 2010

First Posted (Estimate)

May 27, 2010

Study Record Updates

Last Update Posted (Estimate)

May 27, 2010

Last Update Submitted That Met QC Criteria

May 26, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OTOTOXICITY RESEARCH IN PD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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