Prospective, Interventional Study to Iivestigate the Efficiency and Biocompatibility in Hemodiafiltration Procedure
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- removal of small and medium molecules
研究概览
简要总结
Hemodiafiltration is a modern, increasingly used special hemodialysis method. Compared to hemodialysis, it allows greater clearance of medium- and high-molecular-weight molecules. Modern hemofiltration membranes are approaching the properties of the glomerular membrane in their properties.
During hemodiafiltration, blood contact with the semipermeable membrane and blood lines causes activation of the coagulation system, so anticoagulation during the procedure is absolutely necessary. Heparin is routinely used as a method of anticoagulation in hemodiafiltration. Regional citrate anticoagulation is used primarily in patients with risk of bleeding.
The purpose of our study is to evaluate the kinetics of citrate, calcium, and magnesium during hemodiafiltration and citrate anticoagulation, and in these way optimizing the citrate anticoagulation protocol during hemodiafiltration, and to compare the clearance of small and medium molecules between the two anticoagulations (citrate and heparin). The purpose of the study is also to compare biocompatibility parameters for heparin and citrate anticoagulation in hemodiafiltration.
详细描述
Aim of the study
Hemodiafiltration is a modern, increasingly used special hemodialysis method. Compared to hemodialysis, it allows greater clearance of medium- and high-molecular-weight molecules. Modern hemofiltration membranes are approaching the properties of the glomerular membrane in their properties.
During hemodiafiltration, blood contact with the semipermeable membrane and blood lines causes activation of the coagulation system, so anticoagulation during the procedure is absolutely necessary. Heparin is routinely used as a method of anticoagulation in hemodiafiltration. Regional citrate anticoagulation is used primarily in patients with risk of bleeding.
The purpose of our study is to evaluate the kinetics of citrate, calcium, and magnesium during hemodiafiltration and citrate anticoagulation, and in these way optimizing the citrate anticoagulation protocol during hemodiafiltration, and to compare the clearance of small and medium molecules between the two anticoagulations (citrate and heparin). The purpose of the study is also to compare biocompatibility parameters for heparin and citrate anticoagulation in hemodiafiltration.
Hypothesis
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
- •CKD on dialysis
排除标准
- •AKI on dialysis
- •patients on anticoagulant therapy
- •systemic bacterial infection
研究组 & 干预措施
Heparin anticoagulation
Heparin anticoagulation in hemodiafiltration procedure
干预措施: Heparin anticoagulation (Drug)
Citrate anticoagulation
Hemodiafiltration will be performed with regional citrate anticoagulation
干预措施: Citrate anticoagulation (Drug)
结局指标
主要结局
removal of small and medium molecules
时间窗: during 4 hour dialysis
The removal of small and medium molecules is different comparing citrate and heparin anticoagulation.
次要结局
- biocompatibility(during 4 hour dialysis)
研究者
Milena Andonova
MD
University Medical Centre Ljubljana