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Protective Effect of N-acetylcysteine Against From Ototoxicity

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01271088
First Posted: January 6, 2011
Last Update Posted: November 16, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ismail Kocyigit, TC Erciyes University
  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
Intervention Model: Parallel Assignment
Masking: None (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 Ismail Kocyigit, TC Erciyes University:

Primary Outcome Measures:
  • Threshold hearing levels [ Time Frame: 4 weeks ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01271088


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: January 5, 2011
First Posted: January 6, 2011
Last Update Posted: November 16, 2011
Last Verified: November 2011

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

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