跳至主要内容
临床试验/NCT06561191
NCT06561191招募中不适用

Effects of Dialyzer Characteristics and Dialysis Mode on Functional Properties of Albumin in Patients With Chronic Hemodialysis Treatment

Universität Duisburg-Essen2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
Level of irreversibly oxidized albumin HNA-2

研究概览

简要总结

Hemodialysis treatment enables patients with end-stage chronic kidney disease to survive. At the same time, however, this treatment also increases cardiovascular mortality, in particular due to a chronically increased level of inflammation and usually incomplete removal of uraemic toxins. Both of these are closely linked with the functional properties of albumin.

The aim of this study is to investigate the effects of various parameters of dialysis, in particular dialyzer properties and dialysis mode on the functional properties of albumin and to what extent these parameters can be used therapeutically, to improve the treatment quality of hemodialysis treatment in the long term by modifying albumin functional properties.

Our own preliminary work in this field and the current state of research indicate that, for example, the use of high-flux dialyzers can contribute to a reduction of the oxidative stress level. It also appears possible that treatment mode (haemodiafiltration instead of haemodialysis) may also have an effect on the binding and detoxification efficiency of albumin and thus on the removal of uraemic toxins.

Previous results have mostly been collected in observational studies. As a proof-of-concept study, this study will further investigate the concrete therapeutic applicability in an interventional study design.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Sequential
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

  • 18 years or older at least 3 month of hemodialysis treatment (3x/week) with constant dialysis treatment regimen

排除标准

  • Age ≤ 18 years
  • Less than three months of regular (3x/week) hemodialysis treatments or less than 3 treatments/week
  • Acute or chronic liver disease (Child stage A or higher or fulfillment of the of the Kings College criteria)
  • Infusion of commercial human albumin (e.g. in the context of ascites drainage) in the last three months prior to study inclusion
  • Acute or severe chronic infections
  • Acute tumor disease

结局指标

主要结局

Level of irreversibly oxidized albumin HNA-2

时间窗: after 9 month

change of human mercaptalbumin-2 HNA-2

Level of albumin binding and detoxification efficiency

时间窗: after 9 month

Change of albumin binding and detoxification efficiency, meausurement according to PMID: 37558390

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kristina Boss

PD Dr. med. Kristina Boss

Universität Duisburg-Essen

研究点 (2)

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