The Microcirculation, Dialysis Modality and Sequestered Salt
Recruiting · NCT06327750 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
2 locations listed.
- Niercentrum aan de Amstel (Elyseklinieken) - Amstelveen, North Holland, Netherlands
- Dianet Amsterdam - Amsterdam, North Holland, Netherlands