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CompletedNCT01271088Updated Nov 16, 2011

Protective Effect of N-acetylcysteine Against From Ototoxicity

A Phase 2/3 interventional study of N-acetylcysteine in Hearing Loss, Extreme, sponsored by TC Erciyes University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-11-16.

Sponsored by TC Erciyes University · Phase 2/3, Interventional, and Prevention

Phase
Phase 2/3
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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

Read the detailed description

NAC, a thiol-containing antioxidant because of this,we want to investigate antioxidant status.

02

Conditions studied

  • Hearing Loss, Extreme

Keywords

  • ototoxicity
  • aminoglycoside
  • vancomycine
  • peritoneal dialysis
  • peritonitis
03

In context

Deafness

160 studies on the registry are indexed under Deafness; 46 are open to participants now.

This study's enrollment of 60 is above the median of 43 across 106 interventional studies indexed under Deafness.

Browse Deafness studies →

Lead sponsor

TC Erciyes University is the lead sponsor of 349 studies on the registry; 74 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    N-acetylcysteine

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

    Drug: N-acetylcysteine

  • No intervention
    Control

    Vancomycine and/or amikacin alone

    Drug: N-acetylcysteine

Interventions

  • N-acetylcysteine 600 mg twice a day,one week after administration of antibiotics

    Also known as: NAC

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4 weeks

07

Study locations

1 site
  • Erciyes University
    Kayseri, 38039, Turkey
08

References and documents

Publications

  • 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. PubMed 25073872 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 16, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01271088
Responsible party
Ismail Kocyigit (TC Erciyes University Department of Nephrology, TC Erciyes University) — Principal investigator
First posted
Jan 6, 2011
Start date
Jun 2010
Primary completion
Nov 2011
Completion
Nov 2011
Last update
Nov 16, 2011

Study contacts

Ismail Kocyigit, MD
principal investigator · TC Erciyes University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Acetylcysteine

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