DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Protective Effect of N-acetylcysteine Against From Ototoxicity

Information source: TC Erciyes University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hearing Loss, Extreme

Intervention: N-acetylcysteine (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: TC Erciyes University

Official(s) and/or principal investigator(s):
Ismail Kocyigit, MD, Principal Investigator, Affiliation: Erciyes University


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

Clinical Details

Official title: Phase 3 Study of Protective Effect of N-acetylcysteine Against From Ototoxicity

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Threshold hearing levels

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


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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


- 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

Locations and Contacts

Erciyes University, Kayseri 38039, Turkey
Additional Information

Starting date: June 2010
Last updated: November 15, 2011

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017