The Microcirculation, Dialysis Modality and Sequestered Salt

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.

Conditions

• End-stage Renal Disease

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

Sponsors & Collaborators

• Dutch Kidney Foundation

  collaborator OTHER

• Niercentrum aan de Amstel

  collaborator UNKNOWN

• B.Braun Avitum AG

  collaborator INDUSTRY

• Amsterdam UMC, location VUmc

  lead OTHER

Principal Investigators

• Muriel PC Grooteman, MD PhD · Amsterdam UMC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-30

Primary Completion

2027-12-31

Completion

2027-12-31