A Randomized Prospective Trial of N-acetyl Cystein in Patients With Peritoneal Dialysis
试验速览
- 阶段
- 4 期
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Peritoneal membrane function
研究概览
简要总结
Peritoneal fibrosis is one of the major causes of technical failure in patients on peritoneal dialysis (PD) for long period of time. Although the exact mechanisms of peritoneal damage during PD still remain unclear, generation of reactive oxygen species may be responsible for progressive membrane dysfunction. N-acetylcysteine (NAC)is a powerful antioxidant shown to protect peritoneal fibrosis in peritoneal dialysis animal model. In this study the researchers investigated the hypothesis that NAC protect peritoneal membrane damage.
详细描述
N-Acetylcysteine (NAC) is known to be relatively safe and beneficial in peritoneal dialysis patient at a dose of 1200 mg per day. Patients will be randomly assigned to NAC and control group and prescribed according to the protocol. At 2 and 6 month, Peritoneal equilibrium test (PET) will be performed with blood sampling.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Maintenance peritoneal dialysis at least 3 months
- •Patients who are able and willing to understand, sign and date an informed consent document, and authorize access to protected health information
排除标准
- •Episode of peritonitis at least 3 months
- •Episodes of admission due to other disease at lease 3 months
- •Liver disease
- •Allergic history with N-acetylcysteine
研究组 & 干预措施
N-acetylcysteine
N-acetylcysteine in stable peritoneal dialysis patients
干预措施: N-acetylcysteine (Drug)
结局指标
主要结局
Peritoneal membrane function
时间窗: 6 months
Changes in peritoneal membrane function (Δ D/Pcreatinine, ΔD/Purea) with peritoneal equilibrium test
次要结局
- Oxydative stress status(6 months)
- Mesothelial cell transformation (Epithelial to Mesenchymal Transition)(6 month)
- Residual renal function(6 month)
- Peritoneal membrane function(2 months)