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NOT YET RECRUITING
NCT06327750
NA

The Microcirculation, Dialysis Modality and Sequestered Salt

Sponsor: Amsterdam UMC, location VUmc

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

22

Start Date

2024-06

Completion Date

2027-12

Last Updated

2024-03-25

Healthy Volunteers

No

Interventions

DEVICE

Hemodialysis (DNa = PNa)

High-flux hemodialysis with an expected zero diffusive sodium balance (DNa = PNa)

DEVICE

Hemodialysis (DNa<PNa)

High-flux hemodialysis with expected diffusive sodium efflux (DNa\<PNa, difference: 3 mmol/L)

DEVICE

Hemodialysis after isolated ultrafiltration (DNa=PNa)

High-flux hemodialysis after isolated ultrafiltration with an expected zero diffusive sodium balance (DNa=PNa)

DEVICE

High volume hemodiafiltration (DNa=PNa)

High volume hemodiafiltration with an expected zero diffusive sodium balance (DNa=PNa) Convection volume: ≥23L/session

DEVICE

High volume hemodiafiltration (DNa<PNa)

High volume hemodiafiltration with expected diffusive sodium efflux (DNa\<PNa, difference: 3 mmol/L) Convection volume: ≥23L/session