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
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
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Erciyes University, Kayseri 38039, Turkey
Additional Information
Starting date: June 2010
Last updated: November 15, 2011
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