Comparison of Citrate and Heparin Anticoagulation During Hemodialysis With Medium Cut-off Polyarylethersulphone- Polyvinylpirrolidone (Theranova) Membrane
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Clearance of phosphate
研究概览
简要总结
The purpose of the study is to compare the efficiency and biocompatibility of citrate and heparin anticoagulation during hemodialysis with medium cut-off polyarylethersulphone-polyvinylpirrolidone membrane (Theranova®).
详细描述
The purpose of the study is to compare the efficiency and biocompatibility of citrate and heparin anticoagulation during hemodialysis (HD) with PES-PVP membrane. The research will be performed as a prospective clinical trial and will include 35 patients. Every patient will have 2 HD procedures with PES-PVP membrane in a randomized order: 1 with unfractionated heparin (UFH) and 1 with 8% trisodium citrate. We will compare the efficiency of both types of anticoagulation by measuring overall and instantaneous clearances of small, middle and protein-bound molecules (urea, creatinine, phosphate, β2-microglobulin, p-cresol). Biocompatibility will be evaluated by measuring activation of: complement (serum concentration of C3a and C5a), leukocytes (serum concentration of myeloperoxidase) and thrombocytes (serum concentration of PF4). We will also monitor complete blood count for occurrence of leukopenia and thrombocytopenia. After the HD electron microscopy of the membrane will be done in the proportion of included patients to evaluate adsorption of cells and formation of blood clots on the membrane.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •patient on chronic hemodialysis
- •age 18 years old or more
- •being able to give an informed consent to participate in the survey
排除标准
- •on therapeutic anticoagulation
- •citrate or heparin contraindicated
- •citrate or heparin intolerance
- •acute renal failure
结局指标
主要结局
Clearance of phosphate
时间窗: At the end of each hemodialysis procedure.
Overall and instantaneous clearance of phosphate.
Clearance of beta-2 microglobulin
时间窗: At the end of each hemodialysis procedure.
Overall and instantaneous clearance of beta-2 microglobulin.
Serum concentration of C3a, C5a, myeloperoxidase and PF-4
时间窗: At the start, after 15 minutes and at the end of each hemodialysis procedure.
Blood for the laboratory measurements will be taken from the arterial line.
次要结局
- White blood cell count(At the start, after 15 minutes and at the end of each hemodialysis procedure.)
- Clearance of p-cresol(At the end of each hemodialysis procedure.)
- Clearance of urea(At the end of each hemodialysis procedure.)
- Clearance of creatinine(At the end of each hemodialysis procedure.)
- Blood platelet count(At the start, after 15 minutes and at the end of each hemodialysis procedure.)
研究者
Marija Malgaj Vrečko
Principal Investigator
University Medical Centre Ljubljana