The Microcirculation, Dialysis Modality and Sequestered Salt

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-30

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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The life expectancy of patients with end-stage kidney disease (ESKD) is poor. Post-dilution online hemodiafiltration (HDF) is associated with a lower mortality than standard hemodialysis (HD), especially when a high convection volume is achieved (high-volume HDF; hvHDF). It is unclear, however, why (hv)HDF improves survival. Neither an increased clearance of middle molecular weight uremic toxins, nor an improved bio-incompatibility can explain the difference. As the effects are already observed within 2.5 years, recovery of a functional disorder is more likely than restoration of structural alterations. The recuperation of vascular dysfunction may be the missing piece of the puzzle. Previous literature showed (1) that the microcirculation (MC) is severely disturbed in dialysis patients, (2) excess sodium can bind to glycosaminoglycans in the interstitium and in the glycocalyx of blood vessels without commensurate water retention (sequestered sodium content \[SSC\]) and (3) that in patients with non-dialysis dependent chronic kidney disease, a disturbed SSC is related to capillary rarefaction and dysfunction. Therefore, the present study aims to assess the influences of both the modality (HD and HDF) and the dialysate sodium concentration (DNa) on the SSC and the MC.

Therefore the following hypotheses will be evaluated: (1, 2) treatment with hvHDF improves the SSC and MC, if compared to HD; (3, 4) disorders of the SSC and the MC are influenced by differences between the dialysate sodium \[DNa\] and plasma sodium \[PNa\] concentrations; (5) SSC and MC are interrelated in this patient group.

Conditions

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End-stage Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized cross-over trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hemodialysis (DNa=PNa)

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

Group Type ACTIVE_COMPARATOR

Hemodialysis (DNa<PNa)

Intervention Type DEVICE

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

Hemodialysis after isolated ultrafiltration (DNa=PNa)

Intervention Type DEVICE

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

High volume hemodiafiltration (DNa=PNa)

Intervention Type DEVICE

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

High volume hemodiafiltration (DNa<PNa)

Intervention Type DEVICE

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

Hemodialysis (DNa<PNa)

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

Group Type ACTIVE_COMPARATOR

Hemodialysis (DNa = PNa)

Intervention Type DEVICE

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

Hemodialysis after isolated ultrafiltration (DNa=PNa)

Intervention Type DEVICE

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

High volume hemodiafiltration (DNa=PNa)

Intervention Type DEVICE

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

High volume hemodiafiltration (DNa<PNa)

Intervention Type DEVICE

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

Hemodialysis after isolated ultrafiltration (DNa=PNa)

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

Group Type ACTIVE_COMPARATOR

Hemodialysis (DNa = PNa)

Intervention Type DEVICE

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

Hemodialysis (DNa<PNa)

Intervention Type DEVICE

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

High volume hemodiafiltration (DNa=PNa)

Intervention Type DEVICE

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

High volume hemodiafiltration (DNa<PNa)

Intervention Type DEVICE

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

High volume hemodiafiltration (DNa=PNa)

High volume hemodiafiltration with expected diffusive zero sodium balance (DNa=PNa)

Group Type ACTIVE_COMPARATOR

Hemodialysis (DNa = PNa)

Intervention Type DEVICE

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

Hemodialysis (DNa<PNa)

Intervention Type DEVICE

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

Hemodialysis after isolated ultrafiltration (DNa=PNa)

Intervention Type DEVICE

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

High volume hemodiafiltration (DNa<PNa)

Intervention Type DEVICE

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

High volume hemodiafiltration (DNa<PNa)

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

Group Type ACTIVE_COMPARATOR

Hemodialysis (DNa = PNa)

Intervention Type DEVICE

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

Hemodialysis (DNa<PNa)

Intervention Type DEVICE

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

Hemodialysis after isolated ultrafiltration (DNa=PNa)

Intervention Type DEVICE

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

High volume hemodiafiltration (DNa=PNa)

Intervention Type DEVICE

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

Interventions

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Hemodialysis (DNa = PNa)

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

Intervention Type DEVICE

Hemodialysis (DNa<PNa)

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

Intervention Type DEVICE

Hemodialysis after isolated ultrafiltration (DNa=PNa)

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

Intervention Type DEVICE

High volume hemodiafiltration (DNa=PNa)

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

Intervention Type DEVICE

High volume hemodiafiltration (DNa<PNa)

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No