Short-Term Effects of the FX-Class of Haemodialyser on Quality of Life and Inflammatory Markers in Stable Dialysis Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- KD-QOL
研究概览
简要总结
Background:
The new hollow fibre FX-class of dialysers (Fresenius Medical Care, Bad Homburg, Germany) features a number of technological improvements that may benefit the patient. This includes the use of the advanced high-flux polysulfone membrane, Helixone®, which has an extremely high endotoxin retaining capability. Theoretically leading to reduced systemic inflammation in the patient, which is an important factor for morbidity and mortality with dialysis.
The dialysis membrane is the first to be manufactured using membrane-spinning procedures (nano-controlled spinning technology) that enables the membrane to be modulated at the nano-scale level. The resultant membrane is able to extremely efficiently remove middle molecules, along with minimal loss of albumin.
These features may lead to improved patient outcomes, including reduced systemic inflammation and improved quality of life.
Aims:
- To assess the short-term effects of the FX-class Dialyser on quality of life in stable haemodialysis patients
- To assess the short-term effects of the FX-class Dialyser on inflammatory markers in stable haemodialysis patients.
详细描述
Methods Patient selection All patients in the Joondalup Health Campus satellite dialysis unit will be invited to participate in this study.
Inclusion criteria -
- Age >18years
- Able to provide informed consent
- On haemodialysis for 3 months
Exclusion criteria -
- Active inflammatory, infective or neoplastic process within the last 1 month
- Active major psychiatric condition
- Currently on haemodiafiltration as haemodialysis modality
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
- •Age >18years
- •Able to provide informed consent
- •On haemodialysis for 3 months
排除标准
- •Active inflammatory, infective or neoplastic process within the last 1 month
- •Active major psychiatric condition
- •Currently on haemodiafiltration as haemodialysis modality
结局指标
主要结局
KD-QOL
Feeling Thermometer
次要结局
- IL-6
- TNF-alpha
- hs-CRP
- white cell count
