Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Protective Effect of N-acetylcysteine Against From Ototoxicity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ismail Kocyigit, TC Erciyes University
ClinicalTrials.gov Identifier:
NCT01271088
First received: January 5, 2011
Last updated: November 15, 2011
Last verified: November 2011
  Purpose

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


Condition Intervention Phase
Hearing Loss, Extreme
Drug: N-acetylcysteine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase 3 Study of Protective Effect of N-acetylcysteine Against From Ototoxicity

Resource links provided by NLM:


Further study details as provided by TC Erciyes University:

Primary Outcome Measures:
  • Threshold hearing levels [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 60
Study Start Date: June 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: N-acetylcysteine
N-acetylcysteine: Experimental N-acetylcysteine 600 mg twice daily + vancomycine and/or amikacin
Drug: N-acetylcysteine
N-acetylcysteine 600 mg twice a day,one week after administration of antibiotics
Other Name: NAC
No Intervention: Control
Vancomycine and/or amikacin alone
Drug: N-acetylcysteine
N-acetylcysteine 600 mg twice a day,one week after administration of antibiotics
Other Name: NAC

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01271088

Locations
Turkey
Erciyes University
Kayseri, Turkey, 38039
Sponsors and Collaborators
TC Erciyes University
Investigators
Principal Investigator: Ismail Kocyigit, MD Erciyes University
  More Information

No publications provided

Responsible Party: Ismail Kocyigit, TC Erciyes University Department of Nephrology, TC Erciyes University
ClinicalTrials.gov Identifier: NCT01271088     History of Changes
Other Study ID Numbers: EUTF 2010/32
Study First Received: January 5, 2011
Last Updated: November 15, 2011
Health Authority: Turkey: Ethics Committee
United States: Food and Drug Administration

Keywords provided by TC Erciyes University:
ototoxicity
aminoglycoside
vancomycine
peritoneal dialysis
peritonitis

Additional relevant MeSH terms:
Deafness
Hearing Loss
Ear Diseases
Hearing Disorders
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms
Acetylcysteine
N-monoacetylcystine
Anti-Infective Agents
Antidotes
Antioxidants
Antiviral Agents
Expectorants
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014