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

Primary Purpose

Drug-induced Ototoxicity in Peritoneal Dialysis Patients

Status
Completed
Phase
Phase 2
Locations
Turkey
Study Type
Interventional
Intervention
N-acetylcysteine
Sponsored by
TC Erciyes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Drug-induced Ototoxicity in Peritoneal Dialysis Patients focused on measuring ototoxicity, aminoglycoside, vancomycine, peritoneal dialysis, peritonitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Erciyes University School of Medicine Department of Nephrology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

N-acetylcysteine

Controls

Arm Description

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

Vancomycine and/or amikacin alone

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 17, 2010
Last Updated
May 26, 2010
Sponsor
TC Erciyes University
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1. Study Identification

Unique Protocol Identification Number
NCT01131468
Brief Title
Prevention of Drug Induced Ototoxicity in Peritoneal Dialysis Patients by N-Acetylcysteine
Official Title
The Evaluation of the Protective Effect of N-Acetylcysteine Against Drug Induced Ototoxicity in Peritoneal Dialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
TC Erciyes University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug-induced Ototoxicity in Peritoneal Dialysis Patients
Keywords
ototoxicity, aminoglycoside, vancomycine, peritoneal dialysis, peritonitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
N-acetylcysteine
Arm Type
Experimental
Arm Description
N-acetylcysteine 600 mg twice daily + vancomycine and/or amikacin
Arm Title
Controls
Arm Type
No Intervention
Arm Description
Vancomycine and/or amikacin alone
Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine
Intervention Description
N-acetylcysteine 600 mg twice daily or vancomycine+amikacin alone

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bulent Tokgoz, MD
Organizational Affiliation
Erciyes University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erciyes University School of Medicine Department of Nephrology
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
21551083
Citation
Tokgoz B, Ucar C, Kocyigit I, Somdas M, Unal A, Vural A, Sipahioglu M, Oymak O, Utas C. Protective effect of N-acetylcysteine from drug-induced ototoxicity in uraemic patients with CAPD peritonitis. Nephrol Dial Transplant. 2011 Dec;26(12):4073-8. doi: 10.1093/ndt/gfr211. Epub 2011 May 6.
Results Reference
derived

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

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