Changes of albumin binding capacity during dialysis treatment sessions with Theranova dialyzers – short and midterm results

Not Applicable

• Conditions: N18.5; Chronic kidney disease, stage 5

• Registration Number: DRKS00011638
• Lead Sponsor: niversitätsmedizin RostockKlinik für Innere Medizin II

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-25
• Study Completion: 2020-11-25
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

at least 1 year dialysis; no dialysis associated incidents; safe vascular access; no acute or chronic infectious diseases; no hospital stay in the past 2 weeks; estimated life expectancy> 6 months; no patients with ongoing immunosuppression in post-natal transplantation; patient's consent

Exclusion Criteria

pregnancy

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The main criterion is the characterization of the efficacy of Theranova filters in chronic dialysis patients with regard to the improvement of ABIC and the removal of uremia toxins.The test methods for determining albumin binding capacity (ABIC) were described by Klammt et al. (2008). The ABIC method determines the binding capacity of the Albumin molecule at the binding site II (Gambro-MARS, SPAD (single case albumin dialysis).) The ABIC also correlates inversely with the stage of renal insufficiency in patients with chronic kidney disease, ie, the higher the renal insufficiency the patient has, the worse the ABIC. On days 3, 8 and 22 blood samples are taken before and after the treatment.

Secondary Outcome Measures

Name	Time	Method
The secondary objective is the correlation of further clinical and chemical parameters with the efficacy of the therapy. Are creatinine and urea affected as a surrogate parameter? Is there a positive influence on the protein and phosphate content?