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Protective Effect of N-acetylcysteine Against From Ototoxicity

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ClinicalTrials.gov Identifier: NCT01271088
Recruitment Status : Completed
First Posted : January 6, 2011
Last Update Posted : November 16, 2011
Sponsor:
Information provided by (Responsible Party):
Ismail Kocyigit, TC Erciyes University

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Hearing Loss, Extreme Drug: N-acetylcysteine Phase 2 Phase 3

Detailed Description:
NAC, a thiol-containing antioxidant because of this,we want to investigate antioxidant status.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
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
Study Start Date : June 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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
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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
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Turkey
Erciyes University
Kayseri, Turkey, 38039
Sponsors and Collaborators
TC Erciyes University
Investigators
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Principal Investigator: Ismail Kocyigit, MD TC Erciyes University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ismail Kocyigit, TC Erciyes University Department of Nephrology, TC Erciyes University
ClinicalTrials.gov Identifier: NCT01271088    
Other Study ID Numbers: EUTF 2010/32
First Posted: January 6, 2011    Key Record Dates
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:
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Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Acetylcysteine
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