HD Performance Comparison of Revaclear 200 and Revaclear 400 With Larger-surface Competitor Dialyzers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Dialysis dose Kt/V urea
研究概览
简要总结
The purpose of the study is to show equivalent performance of the Revaclear dialyzer when compared to a dialyzer with larger membrane surface area.
Study design: open, randomized, cross-over, multicentric, controlled prospective
Medical devices: Revaclear 200 versus FX 60 or Revaclear 400 versus FX 100, depending on patient needs
Patients/sample size: 30 adult chronic hemodialysis patients
Treatment: Each patient will be treated by hemodialysis for one week (3 dialysis sessions) with Revaclear dialyzers and one week (3 dialysis sessions) with FX dialyzers.
Objectives: intraindividual comparison of dialysis dose; reduction rates and total removal of urea, phosphate, creatinine and ß2-microglobulin; albumin loss
Primary variable: dialysis dose Kt/V urea
Secondary variable: reduction rates and total removal of urea, phosphate, creatinine and ß2-microglobulin
Safety variable: albumin loss, blood count
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
- 否
入选标准
- •chronic renal failure and stable treatment with hemodialysis or hemodiafiltration for at least 3 months
- •patients aged 18 years or more
- •written consent to participate in the study (informed consent)
- •dialysis via native fistula or Gore-Tex graft capable of providing a blood flow rate of at least 300 mL/min
排除标准
- •single-needle dialysis
- •pregnant and lactating women
- •participation in other interventional studies less than 3 months prior to study start
- •non-compliance with the dialysis prescription
- •hematocrit less than 28%
- •hospitalization
- •antibiotic therapy
- •active infection
- •active cancer
- •known positive serology for HIV, hepatitis B or C
- •serious hemostasis disorders
- •any comorbidity possibly conflicting with the study purpose or procedures
研究组 & 干预措施
FX followed by Revaclear
干预措施: Dialyzer comparison (Other)
Revaclear followed by FX
干预措施: Dialyzer comparison (Other)
结局指标
主要结局
Dialysis dose Kt/V urea
时间窗: 2 weeks (6 consecutive dialysis sessions)
Calculation from pre and post plasma urea concentration or urea nitrogen, session length, ultrafiltration volume and post dialysis weight. Dialysis dose does not have a unit of measure.
次要结局
- Total removal of creatinine, phosphate and ß2-microglobulin(2 weeks (6 consecutive dialysis sessions))
- Reduction rate of urea, creatinine, phosphate and ß2-microglobulin(2 weeks (6 consecutive dialysis sessions))
- Albumin loss(2 weeks (6 consecutive dialysis sessions))