Comparing Hemodiafiltration with and Without Hemoadsorption

Not Applicable

Completed

• Conditions: Hemodialysis; Hemodiafiltration; Hemoadsorption

• Registration Number: NCT06710834
• Lead Sponsor: Hospital Clinic of Barcelona

Brief Summary

Goals: The aim of the study is to assess the efficacy and safety of the combination of HDF + HA compared to HDF. To do this, we will evaluate the elimination of a wide range of molecular weight molecules, including small protein-bound solutes.

Design: Prospective, single-center study. Each patient underwent two dialysis sessions with routine dialysis parameters in which HDF or HDF + HA treatment modality will be compared.

Study subjects: 20 patients, stable on a thrice-weekly hemodialysis program, will be included. Local Ethics Committee will approve the study and patients will give informed consent.

Interventions: Prospective collection of two dialysis sessions. The only difference among the sessions in each patient will be add or no sorbent cartridge. One session with FX60 Cordiax, helixone, Fresenius Medical Care in postdilution on-line hemodiafiltration and another session with the same dialyzer plus HA 130 cartridge. The order of these treatment sessions was randomly. Blood samples for analyses were taken for each patient in the same dialysis session of the week.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study Start: 2024-11-07
• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-11-26
• Study First Posted: 2024-11-29
• Primary Completion: 2025-01-31
• Study Completion: 2025-02-28
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Uremic toxins reduction ratios (RR)	From enrollment to the end of treatment at 4-8 weeks.	Protein bound uremic toxins: p-cresyl sulfate RR, and indoxyl-sulfate RR. Medium and large molecules: ß2-microglobulin (11,800 Da) RR, myoglobin (17,200 Da) RR, kappa FLC (22,500 Da) RR, prolactin (23,000 Da) RR, α1-microglobulin (33,000 Da) RR, α1-acid glycoprotein (41,000 Da) RR, and lambda FLC (45,000 Da) RR.

Secondary Outcome Measures

Name	Time	Method
Uremic toxins reduction ratios	From enrollment to the end of treatment at 4-8 weeks	Urea RR (60 Da), creatinine RR (113 Da), and albumin (66,000 Da)

Trial Locations

Locations (1)

Hospital Clínic of Barcelona; 🇪🇸 Barcelona, Spain