Effectiveness of High-volume Online Hemodiafiltration Compared to Standard Volume Online Hemodiafiltration. A Prospective, Multicenter, Randomized, Open-labelled Interventional Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 12
- 主要终点
- changes in the serum concentration of β2 microglobulin
研究概览
简要总结
Online hemodiafiltration (HDF) may improve clinical outcome in end-stage renal disease. The supported mechanism is the improved clearance of uremic toxins by convective transporter. However, It has not been elucidated which convection volume is optimal, especially in Asia. A total of 60 participants receiving conventional hemodialysis will be randomly assigned to receive either high dose convective volume (33-43 L/treatment) post-dilution online HDF or standard dose (16.8-21.5 L/treatment) for 24 weeks. The primary outcome is the change of serum β2 microglobulin levels between baseline and after 24 weeks. The secondary outcomes will include changes in the nutritional markers, inflammatory markers, and blood pressure from baseline to after treatment.
This would be the first multicenter prospective, randomized controlled trial to determine whether large convective volume improves the treatment efficacy in Korean patients undergoing post-dilution online HDF.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients on thrice-weekly standard hemodialysis for > 3 months
- •Patients with a vascular access capable of delivering consistently a high blood flow rates ( ≥ 300 mL/min)
- •Patients willing to provide written informed consent.
排除标准
- •Patients with active infectious or uncontrolled inflammatory disorders
- •Patients with any uncontrolled malignant disease
- •Patients with recent major cardiovascular disease during the last 6 months
- •Patients who are likely to receive kidney transplant within the following 1 year
- •Patients whose life expectancy < 12 months
- •Patients considered by investigator to have difficulty in participation
研究组 & 干预措施
Standard Dose online HDF
Proposed target convection volume; 16.8-21.5 L/treatment (70-90 mL/min)
干预措施: Standard Dose Online HDF (Procedure)
High Dose online HDF
Proposed target convection volume; 33-43 L/treatment (140-180 mL/min).
干预措施: High Dose Online HDF (Procedure)
结局指标
主要结局
changes in the serum concentration of β2 microglobulin
时间窗: between baseline and 24 weeks after treatment
次要结局
- Inflammatory markers(24 weeks)
- Intradialytic hypotension(24 weeks)
- Quality of Life(baseline and 24 weeks after treatment)
- Dialysis Adequacy(24 weeks)
- Nutritional status(24 weeks)
研究者
Sung Gyun Kim
Professor
Korean Hemodialysis Study Group