Hemoadsorption, Hemodiafiltration, Hemodialysis
Conditions
Keywords
Adsorption, Convection, Hemodiafiltration, Efficacy
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.
Interventions
DEVICEHemoadsorption cartridge
HA 130 cartridge
DEVICEHemodiafiltration
Postdilutional hemodiafiltration
Sponsors
Hospital Clinic of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Spain
Outcome results
None listed