Health TrialsbyHealthPanel

The Microcirculation, Dialysis Modality and Sequestered Salt

ConditionEnd-stage Renal Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAmsterdam UMC, location VUmc

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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%

Trial design

Design model

Crossover

Treatments tested in this trial

  • Hemodialysis (DNa = PNa)

    Device

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

  • Hemodialysis (DNa<PNa)

    Device

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

  • Hemodialysis after isolated ultrafiltration (DNa=PNa)

    Device

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

  • High volume hemodiafiltration (DNa=PNa)

    Device

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

  • High volume hemodiafiltration (DNa<PNa)

    Device

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

Treatment groups

23 Participants
are divided into 5 treatment groups
Group A: Hemodialysis (DNa=PNa)Active comparator 4 interventions
Group B: Hemodialysis (DNa<PNa)Active comparator 4 interventions
Group C: Hemodialysis after isolated ultrafiltration (DNa=PNa)Active comparator 4 interventions
Group D: High volume hemodiafiltration (DNa=PNa)Active comparator 4 interventions
Group E: High volume hemodiafiltration (DNa<PNa)Active comparator 4 interventions

Trial outcomes

Primary outcomes

1

Sequestered salt content (SSC) in muscle

SSC in muscle tissue measured with a 7 Tesla 23-Sodium MRI

Time frame
up to 20 weeks; assessed every 4 weeks before the last dialysis session of each treatment period (i.e. 5 times in total)

Secondary outcomes

1

Sequestered salt content (SSC) in the skin

SSC in the skin measured with a 7 Tesla 23-Sodium MRI

Time frame
up to 20 weeks; assessed every 4 weeks before the last dialysis session of each treatment period (i.e. 5 times in total)
2

Skin microcirculation

Skin microcirculatory perfusion/vasoreactivity (arbitrary units) measured with a laser speckle contrast analysis (LASCA) perfusion imager

Time frame
up to 20 weeks; assessed every 4 weeks before the last dialysis session of each treatment period (i.e. 5 times in total)
3

Intradialytic hypotension

A systolic blood pressure (SBP) ≤ 90 mmHg in patients with a pre-dialysis SBP \< 160 mmHg and a SBP \< 100 mmHg in patients with a pre-dialysis SBP ≥ 160 mmHg.

Time frame
up to 4 hours (=one dialysis treatment); assessed during all dialysis sessions (12 treatments per intervention, measured 4x/hour)
4

Change in intradialytic blood pressure

Change in systolic and diastolic blood pressure (mmHg) during one dialysis session

Time frame
up to 4 hours (=one dialysis treatment); assessed during all dialysis sessions (12 treatments per intervention, measured 4x/hour)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Amsterdam UMC, location VUmc

Lead sponsor

Dutch Kidney Foundation

Collaborator

Niercentrum aan de Amstel

Collaborator

B Braun Medical supplies trial fluids

Collaborator

Source ClinicalTrials.gov
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