Protective Effect of N-acetylcysteine Against From Ototoxicity
Phase 3 Study of Protective Effect of N-acetylcysteine Against From Ototoxicity
1 other identifier
interventional
60
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2010
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 5, 2011
CompletedFirst Posted
Study publicly available on registry
January 6, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedNovember 16, 2011
November 1, 2011
1.4 years
January 5, 2011
November 15, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
N-acetylcysteine
EXPERIMENTALN-acetylcysteine: Experimental N-acetylcysteine 600 mg twice daily + vancomycine and/or amikacin
Control
NO INTERVENTIONVancomycine and/or amikacin alone
Interventions
N-acetylcysteine 600 mg twice a day,one week after administration of antibiotics
Eligibility Criteria
You may qualify if:
- End-stage renal disease
- Undergoing continuous ambulatory peritoneal dialysis as a renal replacement therapy
- Developing the first continuous ambulatory peritoneal dialysis related peritonitis episode
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Erciyes University
Kayseri, 38039, Turkey (Türkiye)
Related Publications (1)
Kocyigit I, Vural A, Unal A, Sipahioglu MH, Yucel HE, Aydemir S, Yazici C, Ilhan Sahin M, Oymak O, Tokgoz B. Preventing amikacin related ototoxicity with N-acetylcysteine in patients undergoing peritoneal dialysis. Eur Arch Otorhinolaryngol. 2015 Oct;272(10):2611-20. doi: 10.1007/s00405-014-3207-z. Epub 2014 Jul 30.
PMID: 25073872DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ismail Kocyigit, MD
TC Erciyes University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- TC Erciyes University Department of Nephrology
Study Record Dates
First Submitted
January 5, 2011
First Posted
January 6, 2011
Study Start
June 1, 2010
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
November 16, 2011
Record last verified: 2011-11