Protective Effect of N-acetylcysteine Against From Ototoxicity

Hearing Loss, Extreme Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01271088
• Other study ID #: EUTF 2010/32
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 5, 2011
• Last updated: November 15, 2011
• Start date: June 2010
• Est. completion date: November 2011

Study information

• Verified date: November 2011
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics CommitteeUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Extreme

Intervention

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

Locations

Country	Name	City	State
Turkey	Erciyes University	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks	No