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Protective Effect of N-acetylcysteine Against From Ototoxicity

Primary Purpose

Hearing Loss, Extreme

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 Hearing Loss, Extreme focused on measuring ototoxicity, aminoglycoside, vancomycine, peritoneal dialysis, peritonitis

Eligibility Criteria

18 Years - 65 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
  • 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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

N-acetylcysteine

Control

Arm Description

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

Vancomycine and/or amikacin alone

Outcomes

Primary Outcome Measures

Threshold hearing levels
Ototoxicity was defined as an increase in the auditory threshold by at least 20 dB at any one test frequency, or at least 10 dB at any two adjacent frequencies, or loss of response at three consecutive frequencies between the baseline and follow-up studies in the worse ear.

Secondary Outcome Measures

Full Information

First Posted
January 5, 2011
Last Updated
November 15, 2011
Sponsor
TC Erciyes University
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1. Study Identification

Unique Protocol Identification Number
NCT01271088
Brief Title
Protective Effect of N-acetylcysteine Against From Ototoxicity
Official Title
Phase 3 Study of Protective Effect of N-acetylcysteine Against From Ototoxicity
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TC Erciyes University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Peritonitis is currently one of the leading complications of continuous ambulatory peritoneal dialysis (CAPD). Aminoglycosides and vancomycin are used in the treatment of CAPD peritonitis despite their potential risk for ototoxicity. NAC is a molecule used in the treatment and prophylaxis of many diseases related to oxidative stress. The aim of this study was to examine whether ototoxicity due to antibiotics used in the treatment of CAPD peritonitis can be prevented by N-acetylcysteine
Detailed Description
NAC, a thiol-containing antioxidant because of this,we want to investigate antioxidant status.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Extreme
Keywords
ototoxicity, aminoglycoside, vancomycine, peritoneal dialysis, peritonitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
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: Experimental N-acetylcysteine 600 mg twice daily + vancomycine and/or amikacin
Arm Title
Control
Arm Type
No Intervention
Arm Description
Vancomycine and/or amikacin alone
Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine
Other Intervention Name(s)
NAC
Intervention Description
N-acetylcysteine 600 mg twice a day,one week after administration of antibiotics
Primary Outcome Measure Information:
Title
Threshold hearing levels
Description
Ototoxicity was defined as an increase in the auditory threshold by at least 20 dB at any one test frequency, or at least 10 dB at any two adjacent frequencies, or loss of response at three consecutive frequencies between the baseline and follow-up studies in the worse ear.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: End-stage renal disease Undergoing continuous ambulatory peritoneal dialysis as a renal replacement therapy 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
Ismail Kocyigit, MD
Organizational Affiliation
TC Erciyes University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erciyes University
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
25073872
Citation
Kocyigit I, Vural A, Unal A, Sipahioglu MH, Yucel HE, Aydemir S, Yazici C, Ilhan Sahin M, Oymak O, Tokgoz B. Preventing amikacin related ototoxicity with N-acetylcysteine in patients undergoing peritoneal dialysis. Eur Arch Otorhinolaryngol. 2015 Oct;272(10):2611-20. doi: 10.1007/s00405-014-3207-z. Epub 2014 Jul 30.
Results Reference
derived

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Protective Effect of N-acetylcysteine Against From Ototoxicity

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