Removal of Ligand-bound Iron During Intravenous Iron Administration in Hemodialysis by Large Pore Dialyzers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 3
- 主要终点
- 1. Dialysate Iron levels 2. Plasma levels of advanced oxidation protein products(AOPP)
研究概览
简要总结
The study's hypothesis is that HD with large pore dialyzers remove to the dialysate iron which is bound to potentially dialyzable ligands, after it's release from intravenous iron compound administered during hemodialysis.
详细描述
Most hemodialysis(HD) patients receive during HD intravenous iron compounds, which are composed of an iron core and a sugar polymer shell.
A small percentage of iron from the iron compound is released to the plasma, and may be associated with increased oxidative stress and protein oxidation. The study's hypothesis is that HD with large pore dialyzers may remove to the dialysate iron which is bound to potentially dialyzable ligands, after it's release from intravenous iron compound administered during hemodialysis.
Ligand-bound iron removal is also hypothesized to be affected by dialysate calcium and bicarbonate concentrations, which may affect iron-ligand binding.
Study Specific aims are:
To evaluate
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 88 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic hemodialysis patients
排除标准
- •Acute disease (infection, thrombosis, ischemia, bleeding) Hepatitis B, Hepatitis C or HIV
- •Intravenous iron administration or packed red cell transfusion in the last 3 weeks prior to the study
- •Refusal to comply with limitations in fat containing food during HD with plasma sampling for AOPP evaluation
研究组 & 干预措施
1
large pore dialyzers (FX80, Fresenius, Germany)
干预措施: large pore (FX80) compared to small pore dialyzer (F8HPS) (Device)
2
small pore dialyzers ( F8HPS, Fresenius, Germany)
干预措施: large pore (FX80) compared to small pore dialyzer (F8HPS) (Device)
A
dialysate bicarbonate concentration of 33 mEq/l
干预措施: Dialysate bicarbonate of 33 mEq/L compared to 40 mEq/L (Other)
B
dialysate bicarbonate concentration of 40 mEq/l
干预措施: Dialysate bicarbonate of 33 mEq/L compared to 40 mEq/L (Other)
I
dialysate calcium concentration of 3 mEq/L
干预措施: Dialysate calcium of 3 mEq/L compared to 2.5 mEq/L (Other)
II
dialysate calcium concentration of 2.5 mEq/L
干预措施: Dialysate calcium of 3 mEq/L compared to 2.5 mEq/L (Other)
结局指标
主要结局
1. Dialysate Iron levels 2. Plasma levels of advanced oxidation protein products(AOPP)
时间窗: Before HD, after 1 hour of HD with or without IV iron and at end of HD
次要结局
未报告次要终点