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NCT06327750
The Microcirculation, Dialysis Modality and Sequestered Salt
Conditions: End-stage Renal Disease
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 23
Sponsor: Amsterdam UMC, location VUmc
Location: Niercentrum aan de Amstel (Elyseklinieken) Amstelveen North Holland
Summary
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.
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 \ 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
Source: ClinicalTrials.gov (NCT06327750). StuddyBuddy aggregates publicly available trial information.