跳至主要内容
临床试验/NCT00291603
NCT00291603已完成4 期

Short-Term Effects of the FX-Class of Haemodialyser on Quality of Life and Inflammatory Markers in Stable Dialysis Patients

Sir Charles Gairdner Hospital2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2006年2月最近更新:
适应症

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:

  1. To assess the short-term effects of the FX-class Dialyser on quality of life in stable haemodialysis patients
  2. 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 -

  1. Age >18years
  2. Able to provide informed consent
  3. On haemodialysis for 3 months

Exclusion criteria -

  1. Active inflammatory, infective or neoplastic process within the last 1 month
  2. Active major psychiatric condition
  3. 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

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

研究者

申办方类型
Other

研究点 (2)

Loading locations...

相似试验