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NCT06327750Recruiting

The Microcirculation, Dialysis Modality and Sequestered Salt

Source: ClinicalTrials.gov · Last updated 11 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
23 (estimated)
First submitted
21 Feb 2024
Start date
2 Jun 2026
Primary completion date
May 2028
Lead sponsor
Amsterdam UMC, location VUmc
NCT number
NCT06327750

What you commit to

  • Study type: Interventional
  • Planned participants: 23
  • From 2 Jun 2026 to the primary completion date, May 2028
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Expected transplantation within 6 months
  • Metal implants (e.g. implantable cardioverter defibrillators)

Other illness

  • Life expectancy \< 3 months due to non-renal disease

Other

  • Severe incompliance to dialysis procedure and accompanying prescriptions, especially frequency and duration of dialysis treatment
  • Access recirculation \> 10%
  • Participation in another clinical intervention trial
  • Severe obesity (MRI Ø 60 cm ≈ abdominal circumference ≤ 188 cm)
  • Claustrophobia

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Niercentrum aan de Amstel (Elyseklinieken)
Coordinator of this site? Confirm its status
AmstelveenNetherlandsRecruiting
Dianet Amsterdam
Coordinator of this site? Confirm its status
AmsterdamNetherlandsRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.