An interventional study of Hemodialysis (DNa = PNa) and Hemodialysis (DNa<PNa) in End-stage Renal Disease, sponsored by Amsterdam UMC, location VUmc. Recruiting at 2 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Amsterdam UMC, location VUmc · Not applicable, Interventional, and Treatment
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:
What are the effects on the sequestered sodium content and microcirculation after 4 weeks of treatment with the following dialysis modes?
This study is a randomized cross-over trial. Participants will be subjected to the abovementioned dialysis treatment modes in random order.
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.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's planned enrollment of 23 is below the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Amsterdam UMC, location VUmc is the lead sponsor of 305 studies on the registry; 84 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
High-flux hemodialysis with expected diffusive zero sodium balance (DNa=PNa)
Device: Hemodialysis (DNa<PNa) · Device: Hemodialysis after isolated ultrafiltration (DNa=PNa) · Device: High volume hemodiafiltration (DNa=PNa) · Device: High volume hemodiafiltration (DNa<PNa)
High-flux hemodialysis with expected diffusive sodium efflux (DNa\<PNa, difference: 3 mmol/L)
Device: Hemodialysis (DNa = PNa) · Device: Hemodialysis after isolated ultrafiltration (DNa=PNa) · Device: High volume hemodiafiltration (DNa=PNa) · Device: High volume hemodiafiltration (DNa<PNa)
High-flux hemodialysis after isolated ultrafiltration with expected zero sodium balance (DNa=PNa)
Device: Hemodialysis (DNa = PNa) · Device: Hemodialysis (DNa<PNa) · Device: High volume hemodiafiltration (DNa=PNa) · Device: High volume hemodiafiltration (DNa<PNa)
High volume hemodiafiltration with expected diffusive zero sodium balance (DNa=PNa)
Device: Hemodialysis (DNa = PNa) · Device: Hemodialysis (DNa<PNa) · Device: Hemodialysis after isolated ultrafiltration (DNa=PNa) · Device: High volume hemodiafiltration (DNa<PNa)
High volume hemodiafiltration with expected diffusive sodium efflux (DNa\<PNa, difference: 3 mmol/L)
Device: Hemodialysis (DNa = PNa) · Device: Hemodialysis (DNa<PNa) · Device: Hemodialysis after isolated ultrafiltration (DNa=PNa) · Device: High volume hemodiafiltration (DNa=PNa)
High-flux hemodialysis with an expected zero diffusive sodium balance (DNa = PNa)
High-flux hemodialysis with expected diffusive sodium efflux (DNa\<PNa, difference: 3 mmol/L)
High-flux hemodialysis after isolated ultrafiltration with an expected zero diffusive sodium balance (DNa=PNa)
High volume hemodiafiltration with an expected zero diffusive sodium balance (DNa=PNa) Convection volume: ≥23L/session
High volume hemodiafiltration with expected diffusive sodium efflux (DNa\<PNa, difference: 3 mmol/L) Convection volume: ≥23L/session
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)
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)
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)
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)
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)
Peridialytic blood pressure
Change in systolic and diastolic blood pressure (mmHg) between dialysis sessions
Time frame: up to 24 hours (=one interdialytic day): measured 3x/day every 4 weeks during the last interdialytic day of each treatment period (i.e. 5 times in total)
Change in CK-MB
Marker of cardiac damage, assessment in blood from arterial line of extracorporeal circuit
Time frame: up to 4 hours (=one dialysis treatment); measured before and immediately after the last dialysis session of each treatment period (i.e. 10 times in total)
Change in high sensitivity C-reactive protein (hs-CRP)
Marker of inflammation, assessment in blood from arterial line of extracorporeal circuit
Time frame: up to 4 hours (=one dialysis treatment); measured before and immediately after the last dialysis session of each treatment period (i.e. 10 times in total)
Change in interleukin-6 receptor (IL-6R)
Marker of inflammation, assessment in blood from arterial line of extracorporeal circuit
Time frame: up to 4 hours (=one dialysis treatment); measured before and immediately after the last dialysis session of each treatment period (i.e. 10 times in total)
Change in soluble CD163 (sCD163)
Marker of inflammation, assessment in blood from arterial line of extracorporeal circuit
Time frame: up to 4 hours (=one dialysis treatment); measured before and immediately after the last dialysis session of each treatment period (i.e. 10 times in total)
Change in soluble intercellular adhesion molecule-1 (s-ICAM-1)
Marker of inflammation, assessment in blood from arterial line of extracorporeal circuit
Time frame: up to 4 hours (=one dialysis treatment); measured before and immediately after the last dialysis session of each treatment period (i.e. 10 times in total)
Change in serum glycosaminoglycans
Marker related to sequestered sodium content, assessment in blood from arterial line of extracorporeal circuit
Time frame: up to 4 hours (=one dialysis treatment); measured before and immediately after the last dialysis session of each treatment period (i.e. 10 times in total)
Change in syndecan-1
Marker related to sequestered sodium content, assessment in blood from arterial line of extracorporeal circuit
Time frame: up to 4 hours (=one dialysis treatment); measured before and immediately after the last dialysis session of each treatment period (i.e. 10 times in total)
Change in vascular endothelial growth factor C (VEGF-C)
Marker related to sequestered sodium content, assessment in blood from arterial line of extracorporeal circuit
Time frame: up to 4 hours (=one dialysis treatment); measured before and immediately after the last dialysis session of each treatment period (i.e. 10 times in total)
Change in extracellular vesicles (EVs)
Marker for tissue-injury and inflammation, assessment in blood from arterial line of extracorporeal circuit
Time frame: up to 4 hours (=one dialysis treatment); measured before and immediately after the last dialysis session of each treatment period (i.e. 10 times in total)
Change in skin microcirculation
Change in skin microcirculatory perfusion/vasoreactivity (arbitrary units) measured with a laser speckle contrast analysis (LASCA) perfusion imager during one dialysis session. This will be assessed in 5 patients only.
Time frame: up to 4 hours (=one dialysis treatment); measured before and immediately after the last dialysis session of each treatment period (i.e. 10 times in total)
Change in sequestered salt content (SSC)
Change in SSC measured with a 7 Tesla 23-Sodium MRI during one dialysis session. This will be assessed in 5 patients only.
Time frame: up to 4 hours (=one dialysis treatment); measured before and immediately after the last dialysis session of each treatment period (i.e. 10 times in total)
modified Dialysis symptom index (mDSI)
Standardized questionnaire for the evaluation of physical symptoms and recovery time in dialysis patients, consisting of 13 items. Participants rate the severity of each item on a 5-point likert scale, ranging from 0 ('not at all') to 4 ('very much'). Higher scores indicate a greater perceived severity of symptoms.
Time frame: up to 20 weeks; evaluated every 4 weeks, during/after the last dialysis session of each treatment period
Thirst distress scale (TDS)
The thirst distress scale is a 6-item questionnaire that measures thirst distress on a scale from 1 to 5, where 1 corresponds to 'Strongly disagree' and 5 to 'Strongly agree'. Higher scores indicate greater perceived thirst distress.
Time frame: up to 20 weeks; evaluated every 4 weeks, during/after the last dialysis session of each treatment period
EQ Visual analogue scale (EQ VAS)
The EQ VAS records the patients's self-rated health-related quality of life on a vertical visual analogue scale where 0 means 'the worst health you can imagine' and 100 means 'the best health you can imagine'. Higher scores indicate a better perceived health-related quality of life.
Time frame: up to 20 weeks; evaluated every 4 weeks, during/after the last dialysis session of each treatment period
Plan to share: No — The datasets generated and/or analysed during the current study are not publicly available due to patient privacy and confidentiality restrictions, but are available from the corresponding author on reasonable request.
Started Jun 2026 (actual). Primary completion is estimated for May 2028, 23 months after the start.
Of 347 non-industry interventional studies with no phase under Kidney Failure, Chronic, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 47. This study's planned 23 months is close to that.
Counting every sponsor, half of 425 studies reached it within 23 months; a quarter within 8 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
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Amsterdam UMC, location VUmc →