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The Microcirculation, Dialysis Modality and Sequestered Salt

Sponsor: Amsterdam UMC, location VUmc • ClinicalTrials.gov ID: NCT06327750

Registry updated: 2026-09-11

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Description

The aim of this clinical trial is to investigate the effect of 5 different dialysis treatments (combinations of dialysis mode and dialysis fluid sodium content) on the microcirculation (MC) and sequestered sodium content (SSC) in adult prevalent end-stage kidney disease (ESKD) patients treated with hemodialysis (HD) or hemodiafiltration (HDF). The main questions it aims to answer are: 1. What are the effects on the sequestered sodium content and microcirculation after 4 weeks of treatment with the following dialysis modes? * HDF with an expected zero diffusive sodium balance (Dialysate sodium concentration (DNa)= Plasma sodium concentration (PNa)) compared to * HDF with an expected diffusive sodium efflux (DNa \< PNa, difference 3 mmol/L) compared to * HD with an expected zero diffusive sodium balance (DNa = PNa) compared to * HD with an expected diffusive sodium efflux (DNa \< PNa, difference 3 mmol/L) compared to * Isolated ultrafiltration for 30 minutes followed by HD with an expected zero diffusive sodium balance (DNa = PNa) 2. Are the SSC and MC interrelated in this patient group? This study is a randomized cross-over trial. Participants will be subjected to the abovementioned dialysis treatment modes in random order.

Interventions

Hemodialysis (DNa = PNa) (Device)
High-flux hemodialysis with an expected zero diffusive sodium balance (DNa = PNa)
Hemodialysis (DNa<PNa) (Device)
High-flux hemodialysis with expected diffusive sodium efflux (DNa\<PNa, difference: 3 mmol/L)
Hemodialysis after isolated ultrafiltration (DNa=PNa) (Device)
High-flux hemodialysis after isolated ultrafiltration with an expected zero diffusive sodium balance (DNa=PNa)
High volume hemodiafiltration (DNa=PNa) (Device)
High volume hemodiafiltration with an expected zero diffusive sodium balance (DNa=PNa) Convection volume: ≥23L/session
High volume hemodiafiltration (DNa<PNa) (Device)
High volume hemodiafiltration with expected diffusive sodium efflux (DNa\<PNa, difference: 3 mmol/L) Convection volume: ≥23L/session

Eligibility criteria

Inclusion Criteria: * Age ≥18 years * Treatment with HD or HDF 3 x per week during at least 4 hours for at least 3 months * Blood flow rate feasiblity of ≥350 ml/min * Residual diuresis \<200 ml/day * Plasma Na before dialysis 137-145 mmol/L at baseline * spKt/Vurea ≥ 1.2 * Ability to understand study procedures and willingness to provide informed consent Exclusion Criteria: * Severe incompliance to dialysis procedure and accompanying prescriptions, especially frequency and duration of dialysis treatment * Life expectancy \< 3 months due to non-renal disease * Expected transplantation within 6 months * Access recirculation \> 10% * Participation in another clinical intervention trial * Metal implants (e.g. implantable cardioverter defibrillators) * Severe obesity (MRI Ø 60 cm ≈ abdominal circumference ≤ 188 cm) * Claustrophobia

Conditions

End-stage Renal Disease

Locations

Niercentrum aan de Amstel (Elyseklinieken) — Amstelveen, North Holland, Netherlands
Dianet Amsterdam — Amsterdam, North Holland, Netherlands

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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