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The Microcirculation, Dialysis Modality and Sequestered Salt

Status: Not_yet_recruiting
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Contact Information
Primary
Muriel PC Grooteman, MD PhD
mpc.grooteman@amsterdamumc.nl
+3120 566 5990
Backup
Sabrine Chaara, MD
s.chaara@amsterdamumc.nl
+316463173499
Time Frame
Start Date: 2024-06
Completion Date: 2027-12
Participants
Target number of participants: 22
Treatments
Active_comparator: Hemodialysis (DNa=PNa)
High-flux hemodialysis with expected diffusive zero sodium balance (DNa=PNa)
Active_comparator: Hemodialysis (DNa<PNa)
High-flux hemodialysis with expected diffusive sodium efflux (DNa\<PNa, difference: 3 mmol/L)
Active_comparator: Hemodialysis after isolated ultrafiltration (DNa=PNa)
High-flux hemodialysis after isolated ultrafiltration with expected zero sodium balance (DNa=PNa)
Active_comparator: High volume hemodiafiltration (DNa=PNa)
High volume hemodiafiltration with expected diffusive zero sodium balance (DNa=PNa)
Active_comparator: High volume hemodiafiltration (DNa<PNa)
High volume hemodiafiltration with expected diffusive sodium efflux (DNa\<PNa, difference: 3 mmol/L)
Related Therapeutic Areas
Sponsors
Collaborators: Dutch Kidney Foundation, Niercentrum aan de Amstel, B.Braun Avitum AG
Leads: Amsterdam UMC, location VUmc

This content was sourced from clinicaltrials.gov