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The Microcirculation, Dialysis Modality and Sequestered Salt

RecruitingNAAges 18 Years - anyAllAmsterdam UMC, location VUmc
NCT06327750 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 (DN

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📋 Eligibility rules (as published)
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
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What it tests

  • Hemodialysis (DNa = PNa)
  • Hemodialysis (DNa<PNa)
  • Hemodialysis after isolated ultrafiltration (DNa=PNa)
  • High volume hemodiafiltration (DNa=PNa)
  • High volume hemodiafiltration (DNa<PNa)
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Where

2 sites
Niercentrum aan de Amstel (Elyseklinieken)
Amstelveen, Netherlands
Dianet Amsterdam
Amsterdam, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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