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Protective Effect of N-acetylcysteine Against From Ototoxicity

T

TC Erciyes University

Status and phase

Completed
Phase 3
Phase 2

Conditions

Hearing Loss, Extreme

Treatments

Drug: N-acetylcysteine

Study type

Interventional

Funder types

Other

Identifiers

NCT01271088
EUTF 2010/32

Details and patient eligibility

About

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

Full description

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

Enrollment

60 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

N-acetylcysteine
Experimental group
Description:
N-acetylcysteine: Experimental N-acetylcysteine 600 mg twice daily + vancomycine and/or amikacin
Treatment:
Drug: N-acetylcysteine
Control
No Intervention group
Description:
Vancomycine and/or amikacin alone
Treatment:
Drug: N-acetylcysteine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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