Functionality of Albumin in the Context of Hemodialysis

NCT ID: NCT06561191

Last Updated: 2024-08-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2025-12-31

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.

Conditions

Albumin; Dialysis; Redox State; Uremic; Toxemia

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Arm

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

Group Type: OTHER

Hemodialysis mode, dialyzer type

Intervention Type: OTHER

Change of hemodialysis mode and dialyzer type

Interventions

Hemodialysis mode, dialyzer type

Change of hemodialysis mode and dialyzer type

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universität Duisburg-Essen

OTHER

Sponsor Role: lead

Responsible Party

Kristina Boss

PD Dr. med. Kristina Boss

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital Essen

Essen, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Kristina Boss, PD

Role: CONTACT

kristina.boss@uk-essen.de

00492017231868

Facility Contacts

Kristina Boss, PD

Role: primary

kristina.boss@uk-essen.de

Other Identifiers

2024_EKEA.29

Identifier Type: -

Identifier Source: org_study_id