Comparing Hemodiafiltration with and Without Hemoadsorption

NCT ID: NCT06710834

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-07
• Study Completion Date: 2025-02-28

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.

Conditions

Hemodialysis; Hemodiafiltration; Hemoadsorption

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hemodiafiltration alone

Group Type: ACTIVE_COMPARATOR

Hemodiafiltration

Intervention Type: DEVICE

Postdilutional hemodiafiltration

Hemodiafiltration plus hemoadsorption

Group Type: EXPERIMENTAL

Hemoadsorption cartridge

Intervention Type: DEVICE

HA 130 cartridge

Hemodiafiltration

Intervention Type: DEVICE

Postdilutional hemodiafiltration

Interventions

Hemoadsorption cartridge

HA 130 cartridge

Intervention Type: DEVICE

Hemodiafiltration

Postdilutional hemodiafiltration

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adult patients (age > 18 years)
• More than 6 months on a dialysis program
• Stable in a hemodialysis program
• AV fistula, prosthesis, or tunneled catheter as vascular access
• No residual diuresis (< 200 ml/day)
• Not enrolled in a living donor transplant program
• No immunosuppressive treatment
• Provide written informed consent

Exclusion Criteria

• Chronic inflammatory diseases
• Neoplasms
• Immunosuppressive treatment or chronic treatment with anti-inflammatory drugs
• Dysfunctional AV fistula or catheter
• Single-needle dialysis
• Kt/V less than 1.3 or PRU < 70%
• Scheduled living donor kidney transplant

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

Sponsors

Hospital Clinic of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Francisco Maduell

Head of Dialysis Section

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Clínic of Barcelona

Barcelona, Barcelona, Spain

Countries

Spain

Other Identifiers

HCB/2024/0704

Identifier Type: -

Identifier Source: org_study_id