A Comparison of Protein-bound and Large Molecular Weight Uremic Toxin Removals With Novel Super High-flux Dialyzer Between Hemodialysis and High Volume Online Hemodiafiltration Modalities : A Crossover Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Protein bound uremic toxin reduction ratio (percent)
研究概览
简要总结
The goal of this prospective, randomized, crossover study is to study about using super high-flux dialyzer in the chronic hemodialysis patients.
The main questions aim to answer are the reduction ratio of protein bound uremic toxins
Participants will undergone the pre-dilution online hemodiafiltration and conventional hemodialysis for each 8 weeks followed by washout phase for 4 weeks.
详细描述
Other secondary outcomes that the researcher wants to study are
- The reduction ratio of Beta2microglobulin, kappa and lambda free light chain
- Serum albumin and dialysate albumin loss
- Quality of life, muscle mass and nutritional status of the patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- 是
入选标准
- •Chronic hemodialysis patients in King Chulalongkorn Memorial hospital
- •Residual renal function less than 100 ml/day
排除标准
- •Dialyzer allergy
- •Malnutrition requiring intradialytic parenteral nutrition
- •Cirrhosis child C or decompensated cirrhosis
- •Active uncontrolled infection
- •Active cardiovascular disease
- •Advanced stage malignancy
- •Predicted to be undergone living related kidney transplant within 1 year
结局指标
主要结局
Protein bound uremic toxin reduction ratio (percent)
时间窗: 8 weeks
The reduction ratio of indoxyl sulfate will be calculated as percent by pre and post dialysis data. The measurement will take place in the pre-dialysis of the first and the last time of intervention
次要结局
- Beta2 microglobulin, kappa and lambda free light chain and urea reduction ratio (percent)(8 weeks)
- Quality of life assessment in each group(8 weeks)
- Serum albumin and dialysate albumin loss(8 weeks)
研究者
Rossanun Shoosanglertwijit, MD
Principle investigator
Chulalongkorn University