NCT03211676已完成不适用
Comparison of Hemodialysis With Medium Cut-off Dialyzer (Theranova) and High Flux Dialyzer on Removal of Small and Middle Size Molecules, Inflammatory Parameters and Oxidative Stress. An Open Cross Over Randomized Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Removal of myoglobin
研究概览
简要总结
The aim of this study is to evaluate the removal of midle molecules and inflammatory cytokines with the Theranova-500 ™ dialyzer (medium cut-off membrane, Baxter®) versus a high flux dialyzer Elisio-21H ™ (High-flux membrane, Nipro®) in chronic hemodialysis.
Evaluation of nutritional parameters, inflamatory parameters and oxidative stress will also be carried out.
Finally, the investigators will compare hepcidin levels and the erythropoietin resistance index between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- •Age ≥ 18 years
- •Patient suffering from chronic terminal renal failure excluding nephropathy with myelomatous cylinders, hemodialysis for more than 6 months,
- •Patient under dialyser Elisio-21H ™ for more than 3 months
- •Patient including the protocol scheme and able to comply with it
- •Free subject, without guardianship or curatorship or subordination
- •Patients benefiting from a Social Security scheme or benefiting from it through a third party
- •Non-opposition given by the patient after clear and fair information on the study
排除标准
- •Age <18 years
- •Patient with an associated pathology (evolutionary cancer, progressive infectious disease or chronic inflammatory disease) that may excessively influence CRP levels (CRP> 60 mg / L)
- •Patient following another protocol of research or period of exclusion of another protocol
- •Patients not benefiting from a Social Security scheme or not benefiting from it through a third party
- •Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection, and finally patients in emergencies .
- •Pregnant or nursing women, women of childbearing age who do not have effective contraception (hormonal / mechanical: oral, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total ovariectomy ).
结局指标
主要结局
Removal of myoglobin
时间窗: After 3 months
myoglobin Reduction ratio.
次要结局
- comparison of use of erythrpoietin(After 3 months)
- Removal of creatinine(After 3 months)
- comparison of pre dialysis level of SAA(After 3 months)
- Removal of beta2 microglobulin(After 3 months)
- Removal of interleukin 6(After 3 months)
- Removal of leptin(After 3 months)
- Removal of alpha 1 microglobulin(After 3 months)
- Removal of retinol binding protein(After 3 months)
- comparison of pre dialysis level of isoprostan(After 3 months)
- comparison of post dialysis level of albumin(After 3 months)
- Removal of IL-1beta(After 3 months)
- Removal of TNF alpha(After 3 months)
- comparison of pre dialysis level of superoxide dismutase(After 3 months)
- Removal of urea(After 3 months)
- Removal of hyaluronic acid(After 3 months)
- comparison of level of middle molecules and albumin in the dialysate(After 3 months)
- comparison of hemoglobin levels(After 3 months)
- comparison of pre dialysis level of CRP(After 3 months)
- Removal of free light chain kappa(After 3 months)
- Removal of free light chain lambda(After 3 months)
- comparison of pre dialysis level of hepcidin(After 3 months)
- comparison of pre dialysis level of prealbumin(After 3 months)
- Removal of FGF 23 (fibroblast growth factor 23)(After 3 months)
- Removal of prolactin(After 3 months)
- comparison of pre dialysis level of human oxidized LDL(After 3 months)
- comparison of pre dialysis level of albumin(After 3 months)
研究者
研究点 (2)
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