Investigation on the Middle Size Molecule Elimination Characteristics of the FX CorDiax 60 in Relation to the FX 60-Dialyzer
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Removal rate of myoglobin
研究概览
简要总结
Study design: Open, randomized, cross-over, monocentric, controlled, prospective Applied Medical Devices: FX CorDiax 60 (high-flux), FX 60 (high-flux) Patients: 30 adult chronic hemodialysis patients Treatment: Each patient will be treated by post-dilution online hemodiafiltration once with each dialyzer type.
Study objectives: Intraindividual comparison of removal rate of urea, phosphate, ß2-microglobulin (ß2-m), myoglobin, prolactin, alpha1-microglobulin and alpha1-acidglycoprotein and of the albumin loss with different dialyzer membranes during post-dilution online hemodiafiltration.
Primary variable: Removal rate of myoglobin Secondary variable: Removal rate of urea, phosphate, ß2-microglobulin (ß2-m), prolactin, alpha1-microglobulin and alpha1-acidglycoprotein Safety variable: Hematocrit, albumin loss Sample Size: 30 subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- 否
入选标准
- •Patients who are treated by post dilution on-line HDF for at least three months.
- •Patients who reached a dialysis dose (Kt/V) of at least 1.2 at the last two monthly checks,
- •Patients who are on a stable anticoagulation and anemia management,
- •Patients who are clinically stable outlined by the medical history of the patient, based on judgment of principal investigator,
- •Patients who are on a regular thrice weekly HDF schedule,
- •Patients who have a good vascular access (fistula or graft) which enables easy insertion of the needles and suitable effective blood flow (> 300 ml/min),
- •Patients who are able to understand the nature and requirements of the clinical investigation and have given written informed consent,
- •Patients who are aged 18 years or older.
排除标准
- •Patients who do not meet the inclusion criteria,
- •Patients with active HBV, HCV, HIV infection,
- •Patients who are severely malnourished patients as judged by the principal investigator,
- •Patients who are known or suspected to have allergy to the trial products or related products,
- •Patients who are abusing non-legal drugs or alcohol (defined as an average daily intake of more than one liter of beer per day or an equivalent amount of alcohol in other beverages),
- •Patients who have been diagnosed a current active malignant disease,
- •Patients who participate simultaneously in another clinical investigation or in other clinical investigations during the last month,
- •Patients who are uncooperative.
结局指标
主要结局
Removal rate of myoglobin
时间窗: 2 weeks
次要结局
- Removal rate of phosphate(2 weeks)
- Removal rate of ß2-microglobulin (ß2-m)(2 weeks)
- Removal rate of prolactin(2 weeeks)
- Removal rate of alpha1-microglobulin(2 weeks)
- Removal rate of alpha1-acid glycoprotein(2 weeks)
- Hematocrit pre and post-dialysis(2 weeks)
- Albumin loss during dialysis session(2 weeks)
- Removal rate of urea(2 weeks)
研究者
Francisco Maduell
Principal Investigator
Hospital Clinic of Barcelona