New Needle for Two-Needle Hemodialysis
试验速览
- 阶段
- 2 期
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Net change in intracellular oxidative stress and intracellular proinflammatory cytokines levels
研究概览
简要总结
Our preliminary studies have demonstrated that an innovative new design of the hemodialysis venous needle (the needle that returns the cleaned blood from the hemodialysis filter to the patient) with three jets is superior to the standard venous needle because it decreases the velocity and turbulence of the blood when compared with the standard venous needle, it is more efficient in the removal of toxins from the blood, and it is safe and effective. More importantly, our preliminary studies suggested that the new needle causes less damage to the dialysis vascular access and to circulating blood cells and less inflammation and oxidative stress. These will decrease medical complications, the high cost of care and death in dialysis patients. The current study will corroborate the finding of previous studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) end stage renal disease receiving hemodialysis in an ambulatory outpatient dialysis facility (2) male or female, (3) ages 18-80, (4) arterio-venous graft or AV fistula as vascular access,
排除标准
- •patients with fever, infection, inflammation or malignancy will be excluded
结局指标
主要结局
Net change in intracellular oxidative stress and intracellular proinflammatory cytokines levels
时间窗: 4 hours of hemodialysis
The net change in the levels of intracellular IL-6, IL-6 soluble receptor, IL-6 gp130, superoxide, H2O2 and IL-1 during dialysis (difference between pre and post dialysis) using the new venous needle will be compared with the change using the current venous needle.
次要结局
- Net change in oxidative stress and proinflammatory cytokines in plasma(4 hours hemodialysis)