Functionality of Albumin in the Context of Hemodialysis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hemodialysis mode, dialyzer type.
- Who it may be relevant to
- Registry conditions: Albumin, Dialysis, Redox State, Uremic; Toxemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effects of Dialyzer Characteristics and Dialysis Mode on Functional Properties of Albumin in Patients With Chronic Hemodialysis Treatment
Overview
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.
Interventions
- Other Hemodialysis mode, dialyzer type
Change of hemodialysis mode and dialyzer type
Primary outcome measures
- Level of irreversibly oxidized albumin HNA-2 [Time frame: after 9 month]
- Level of albumin binding and detoxification efficiency [Time frame: after 9 month]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- University Hospital Essen — Essen
Identifiers
NCT: NCT06561191 · 2024_EKEA.29