Comparing Hemodiafiltration with and Without Hemoadsorption

Hospital Clinic of Barcelona

Status: Completed

Conditions: Hemodialysis; Hemoadsorption; Hemodiafiltration

Treatments: Device: Hemoadsorption cartridge; Device: Hemodiafiltration

Study type: Interventional

Funder types: Other

Identifiers

NCT06710834

HCB/2024/0704

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Hemodiafiltration alone

Active Comparator group

Treatment:

Device: Hemodiafiltration

Hemodiafiltration plus hemoadsorption

Experimental group

Treatment:

Device: Hemodiafiltration

Device: Hemoadsorption cartridge