Phase 3 Study of Protective Effect of N-acetylcysteine Against From Ototoxicity
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Threshold hearing levels
研究概览
简要总结
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
详细描述
NAC, a thiol-containing antioxidant because of this,we want to investigate antioxidant status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •End-stage renal disease
- •Undergoing continuous ambulatory peritoneal dialysis as a renal replacement therapy
- •Developing the first continuous ambulatory peritoneal dialysis related peritonitis episode
排除标准
- •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
研究组 & 干预措施
Control
Vancomycine and/or amikacin alone
干预措施: N-acetylcysteine (Drug)
N-acetylcysteine
N-acetylcysteine: Experimental N-acetylcysteine 600 mg twice daily + vancomycine and/or amikacin
干预措施: N-acetylcysteine (Drug)
结局指标
主要结局
Threshold hearing levels
时间窗: 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.
次要结局
未报告次要终点
研究者
Ismail Kocyigit
TC Erciyes University Department of Nephrology
TC Erciyes University