Functionality of Albumin in the Context of Hemodialysis

Not Applicable

Recruiting

• Conditions: Albumin; Dialysis; Uremic; Toxemia; Redox State
• Interventions: Other: Hemodialysis mode, dialyzer type

• Registration Number: NCT06561191
• Lead Sponsor: Universität Duisburg-Essen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study Start: 2024-08-01
• Study First Submitted: 2024-08-15
• Study First Submitted QC: 2024-08-17
• Last Update Submitted: 2024-08-17
• Study First Posted: 2024-08-19
• Last Update Posted: 2024-08-19
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Single Arm	Hemodialysis mode, dialyzer type	All patients recieve three month of treatment with hemodialysis, hemodiafiltraten, treatment with high flux dialyzer and treatment with low flux dialyzer

Primary Outcome Measures

Name	Time	Method
Level of irreversibly oxidized albumin HNA-2	after 9 month	change of human mercaptalbumin-2 HNA-2
Level of albumin binding and detoxification efficiency	after 9 month	Change of albumin binding and detoxification efficiency, meausurement according to PMID: 37558390

Trial Locations

Locations (1)

University Hospital Essen; 🇩🇪 Essen, Germany