Prevention of Drug Induced Ototoxicity in Peritoneal Dialysis Patients by N-Acetylcysteine
The Evaluation of the Protective Effect of N-Acetylcysteine Against Drug Induced Ototoxicity in Peritoneal Dialysis Patients
1 other identifier
interventional
60
1 country
1
Brief Summary
The purpose of this study is to determine whether N-acetylcysteine is effective in the prevention of hearing loss in both ears due to aminoglycoside and/or vancomycine induced ototoxicity in peritoneal dialysis patients.
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 Feb 2008
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
February 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 17, 2010
CompletedFirst Posted
Study publicly available on registry
May 27, 2010
CompletedMay 27, 2010
March 1, 2010
2.2 years
May 17, 2010
May 26, 2010
Conditions
Keywords
Study Arms (2)
N-acetylcysteine
EXPERIMENTALN-acetylcysteine 600 mg twice daily + vancomycine and/or amikacin
Controls
NO INTERVENTIONVancomycine and/or amikacin alone
Interventions
N-acetylcysteine 600 mg twice daily or vancomycine+amikacin alone
Eligibility Criteria
You may qualify if:
- End-stage renal disease
- Undergoing continuous ambulatory peritoneal dialysis as a renal replacement therapy
- Clinical diagnosis of a peritonitis episode in a continuous ambulatory peritoneal dialysis patient
- 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 School of Medicine Department of Nephrology
Kayseri, 38039, Turkey (Türkiye)
Related Publications (1)
Tokgoz B, Ucar C, Kocyigit I, Somdas M, Unal A, Vural A, Sipahioglu M, Oymak O, Utas C. Protective effect of N-acetylcysteine from drug-induced ototoxicity in uraemic patients with CAPD peritonitis. Nephrol Dial Transplant. 2011 Dec;26(12):4073-8. doi: 10.1093/ndt/gfr211. Epub 2011 May 6.
PMID: 21551083DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bulent Tokgoz, MD
Erciyes University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 17, 2010
First Posted
May 27, 2010
Study Start
February 1, 2008
Primary Completion
April 1, 2010
Study Completion
May 1, 2010
Last Updated
May 27, 2010
Record last verified: 2010-03