Comparison of Efficacy in Removal of Advanced Glycation End Products (AGEs) Between Super High-flux Hemodialysis and Postdilution Online Hemodiafiltration: A Single-center, Prospective, Open-label, Crossover Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- skin autofluorescence for AGEs
研究概览
简要总结
The goal of this clinical trial is to compare efficacy in advanced glycation end products removal between Super high-flux Hemodialysis and high-volume post-dilution online hemodiafiltration. The main question it aims to answer are
- Efficacy : endothelial dysfunction biomarker (AGEs) in super high-flux hemodialysis compared to online HDF
- Safety profile : Dialysate albumin loss, Intradialytic complication
Participants will be asked to randomized in 2 groups : Super high-flux HD or post dilution ol-HDF Researchers will compare SHF-HD and ol-HDF to see whether SHF-HD could remove AGEs better than ol-HDF
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic HD > 3 months
- •Adequate small molecule uremic toxins removal
- •Kt/v > 1.8 in HD 2 times/week
- •Kt/v > 1.2 in HD 3 times/week
- •BFR > 300 mL/min
- •RKF < 100 ml/day
- •Hemodynamically stable for > 2 weeks
排除标准
- •contraindicated to anticoagulant
- •active malignancy
- •advanced liver disease
结局指标
主要结局
skin autofluorescence for AGEs
时间窗: 24 weeks
SAF was measured by using a certified Autofluorescence Reader (AGE Reader, DiagnOptics, Groningen, The Netherlands). The AGEs reader uses an excitation light source between 300 and 420 nm to illuminate a skin surface that is about 1 cm2 in size and shielded from outside light. A spectrometer (AVS-USB2000, Avantes Inc., Eerbeek, The Netherlands) is used to measure the emission light from the skin in the 300- to 600-nm region using a 200-mm glass fiber.
次要结局
- serum beta 2 microglobulin(At first week, 8th week, 16th week and 24th week)