NCT00267384已完成2 期
N-acetylcysteine Protects From Aminoglycosides Induced Nephrotoxicity
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 2
- 主要终点
- The decrease in glomerular filtration rate (GFR)
研究概览
简要总结
This randomized, double-blind, placebo-controlled clinical trial will be performed to assess the effect of N-acetylcysteine therapy on the incidence of nephrotoxicity among patients hospitalized with an infection and treated with aminoglycosides (AGs). Secondary goals of the study will be as follows: comparison of the mortality rates, and length of hospitalization among patients treated with N-acetylcysteine compared to the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients hospitalized with presumptive gram-negative infection, as assessed by the treating house staff and requiring gentamycin therapy according to an infectious disease specialist decision.
- •Aged between 18 and
- •Recruitment time between starting gentamycin therapy and initiation of the study intervention will be less than 24 hours.
- •Signed informed consent.
排除标准
- •Any known allergy or intolerance to one of the medications in the AG group.
- •Any known allergy or intolerance to N-acetylcysteine.
- •Any immunosuppressive therapy excluding steroid therapy.
- •HIV infection.
- •Non-sepsis-related neutropenia.
- •An estimated creatinine clearance of less than 30 mL/min.
- •Acute renal failure defined as elevation in creatinine level of 0.5 mg/dL above the patient's baseline.
结局指标
主要结局
The decrease in glomerular filtration rate (GFR)
次要结局
未报告次要终点
研究者
Victor Novack
Head, Clinical research center
Soroka University Medical Center
研究点 (2)
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