Crossover Study of Three Groups Comparing the Efficacy of Uremic Toxins Clearance of Expanded Hemodialysis With Two Hemodialysis Membranes for Conventional Hemodialysis and Hemodiafiltration
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- B2-microglobulin reduction rate
研究概览
简要总结
The aim of this study is to quantify the B2-microglobulin reduction rate based on the type of extracorporeal therapy (ET) used: HDx (expanded hemodialysis), HDc (high-flux conventional hemodialysis), or HDF (hemodiafiltration).
And to compare the magnitude of the B2-microglobulin reduction rate based on the type of extracorporeal therapy (ET) used: HDx, HDc, or HDF
详细描述
A controlled, randomized, crossover clinical trial is planned to compare the magnitude of the B2-microglobulin reduction rate in three different extracorporeal therapies (ETs): HDc, HDx, and HDF.
The selection of study participants will be consecutive and for convenience
This study will be divided into six periods: three treatment periods (one for each therapy to be compared) and three of "washout" periods (interspersed between the treatment periods). The treatment periods will last four weeks (12 ET sessions, three per week) and will be preceded by a one-week washout period (three ET sessions)
After inclusion in the protocol, participants will be randomly assigned (with the help of a table of random numbers) to one of three ETs to be evaluated (HDc, HDx, or HDF). Afterwards, the first washout period will begin with high-flow conventional hemodialysis (HDc). At the end of the first washout period, the ET randomly assigned to one of three ETs to be evaluated (HDc, HDx, or HDF), following the sequence: Washout 1 -> Period 1 (HDC, HDx, or HDF) -> Washout 2 -> Period 2, etc.
For each period of ET, there will be two sampling times: baseline and final
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Over 18 years
- •Anuric patients (residual urinary volume ≤ 100 mL/24 h)
- •Intermittent chronic hemodialysis (three sessions per week, of 3.5 to 4 hours each)
- •Without modification of their prescription in the last three months
- •Functional arteriovenous fistula, indwelling vascular access (Qb ≥ 300 mL/min), or both
- •Letter of acceptance to enter the protocol and a signed informed consent.
排除标准
- •Under 18 years
- •Active intake or intake in the last six months of immunosuppressants or systemic steroids
- •Active autoimmune disease
- •Evidence of active systemic infectious event at the time of inclusion or two weeks prior
- •Diagnosis of neoplasia or active oncological disease
- •Hypoalbuminemia (< 3.2 g/dL)
- •Pregnancy or lactation
- •Refusal to participate in the study
结局指标
主要结局
B2-microglobulin reduction rate
时间窗: At final of each period of ET (4 weeks)
B2-microglobulin reduction rate based on the type of extracorporeal therapy (ET) used: HDx, HDc, or HDF.
次要结局
- Interleukin 6 reduction rate(At final of each period of ET (4 weeks))
- Tumor necrosis factor-a reduction rate(At final of each period of ET (4 weeks))
- P-cresol reduction rate(At final of each period of ET (4 weeks))
- Phosphorus reduction rate(At final of each period of ET (4 weeks))
- Urea reduction rate(At final of each period of ET (4 weeks))