Application of the "High-cutoff (HCO1100)" Hemodialyzer to Reduce Chronic Inflammation in Hemodialysis Patients With Elevated CRP Levels
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Inflammation: CRP plasma level and quantity of circulating CD14/16 positive monocytes
研究概览
简要总结
The purpose of this study is to test whether a dialyzer with a higher than usual permeability for proteins can eliminate proinflammatory proteins from the blood of patients on regular maintenance hemodialysis who have chronically elevated levels of inflammation markers such as C-reactive protein (CRP) in their blood.
详细描述
Patients with ESRD on chronic hemodialysis patients frequently have elevated markers of inflammation (e.g. serum CRP values). Hemodialysis may clear the blood from low molecular weight toxins and retention products such as creatinine, potassium, or urea. The dialyzer clearance of middle to high molecular weight substances such as cytokines and cytokine receptors is low. Nearly 50% of chronic dialysis patients have persistent subclinical inflammation which is strongly associated with cardiovascular disease and mortality. The study tests the hypothesis that removal of proteins in the weight range of 10.000-30.000 D via a more permeable dialyzer membrane reduces chronic inflammation in these patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •regular hemodialysis for at least 3 months
- •treatment thrice weekly
- •high-flux hemodialyzer for at least 4 weeks
- •age > 18 years and < 80 years
- •at least one CRP value > 5mg/L within 8 weeks before inclusion
- •able to understand and consent the study
- •written informed consent
排除标准
- •no consent
- •clinically apparent acute infection
- •CRP > 50 mg/L
- •serum albumin < 3,5 mg/L
- •central venous line as dialysis access
- •immunosuppressive medication
- •pregnancy or lactation
- •inclusion into any other interventional trial
研究组 & 干预措施
HCO dialyzer
Hemodialysis with the HCO1100 hemodialyzer membrane with high molecular weight cut off.
干预措施: HCO1100 dialyzer (Device)
Placebo
Regular dialysis using a polyamide high-flux hemodialyzer
干预措施: regular dialysis polyamide (Device)
结局指标
主要结局
Inflammation: CRP plasma level and quantity of circulating CD14/16 positive monocytes
时间窗: 2 weeks
次要结局
- Serum albumin losses(2 weeks)
研究者
Matthias Girndt
Professor of Internal Medicine
Martin-Luther-Universität Halle-Wittenberg