Functionality of Albumin in the Context of Hemodialysis (FACED)

Universität Duisburg-Essen

Status: Enrolling

Conditions: Dialysis; Redox State; Albumin; Uremic; Toxemia

Treatments: Other: Hemodialysis mode, dialyzer type

Study type: Interventional

Funder types: Other

Identifiers

NCT06561191

2024_EKEA.29

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Single Arm

Other group

Description:

All patients recieve three month of treatment with hemodialysis, hemodiafiltraten, treatment with high flux dialyzer and treatment with low flux dialyzer

Treatment:

Other: Hemodialysis mode, dialyzer type