Effect of High Cut-off Membranes on Cardiovascular Function in Patients With End-stage Renal Disease (HICOCARD)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Changes in hyperoxic chemoreflex sensitivity (CHRS) and flow mediated endothelial vasodilatation (FMD)
研究概览
简要总结
The purpose of this study is to determine whether high porous membranes are effective in the treatment of cardiovascular events in chronic dialysis patients.
详细描述
Cardiovascular events are the leading cause of the increased mortality rate of chronic dialysis patients. It is believed that increased micro-inflammation plays an important role in the pathophysiological process of cardiovascular disease. High porous dialysis membranes can better eliminate inflammatory mediators as compared to standard dialysis membranes. In this study, the high porous dialysis membrane HCO1100 is investigated for its potential capability to improve the cardiovascular status of chronic dialysis patients.
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
- •Age ≥ 18 years
- •Dialysis dependent chronic renal failure (CKD 5) in a stable condition
- •Serum albumin at randomisation equal to or above the median of the normal range (pre- dialysis value)
排除标准
- •Diabetes mellitus as the disease underlined end stage renal failure
- •Haemodynamic instability that precludes unsupported dialysis
- •planned surgical interventions <= 4 months at time of inclusion
- •known allergy against dialysis membranes
- •Significant cardiac disease (atrial fibrillation, myocardial infarction within 6 months; unstable angina pectoris; LV-EF < 30%, clinically significant pericardial disease; cardiac amyloidosis)
- •pulmonary disease with chronic hypoxia
- •Advanced disease or significant co-morbidity with poor short term prognosis, necessitating palliation and not subject to active or disease specific treatment
- •Clinically significant liver dysfunction (bilirubin > 1.8mg/dl (30µmol/L))
- •Prior fistula surgery on both arms or other operations or paralysis on both arms
- •Known HIV, HCV infection
- •Alcoholism
- •Active uncontrolled infection
- •Pregnancy or lactation
- •Inability to give informed consent to participate in the study
研究组 & 干预措施
Dialysis treatment with HCO1100
干预措施: HCO 1100 (Device)
结局指标
主要结局
Changes in hyperoxic chemoreflex sensitivity (CHRS) and flow mediated endothelial vasodilatation (FMD)
时间窗: max 15 weeks
Changes of CHRS (ms/mmHg) and FMD (%) between pre- and post- treatment phase with study product HCO1100 dialyzer and at 6 weeks follow up after termination of HCO1100 dialyzer treatment phase will be assessed.
次要结局
- Weekly assessment of albumin plasma levels (g/l)(max 15 weeks)