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| Name | Class |
|---|---|
| Dutch Kidney Foundation | OTHER |
| Niercentrum aan de Amstel | UNKNOWN |
| B.Braun Avitum AG | INDUSTRY |
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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:
What are the effects on the sequestered sodium content and microcirculation after 4 weeks of treatment with the following dialysis modes?
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemodialysis (DNa=PNa) | Active Comparator | High-flux hemodialysis with expected diffusive zero sodium balance (DNa=PNa) |
|
| Hemodialysis (DNa<PNa) | Active Comparator | High-flux hemodialysis with expected diffusive sodium efflux (DNa\ |
|
| Hemodialysis after isolated ultrafiltration (DNa=PNa) | Active Comparator | High-flux hemodialysis after isolated ultrafiltration with expected zero sodium balance (DNa=PNa) |
|
| High volume hemodiafiltration (DNa=PNa) | Active Comparator | High volume hemodiafiltration with expected diffusive zero sodium balance (DNa=PNa) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemodialysis (DNa = PNa) | Device | High-flux hemodialysis with an expected zero diffusive sodium balance (DNa = PNa) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Skin microcirculation | Skin microcirculatory perfusion/vasoreactivity (arbitrary units) measured with a laser speckle contrast analysis (LASCA) perfusion imager | 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) | SSC measured with a 7 Tesla 23-Sodium MRI | up to 20 weeks; assessed every 4 weeks before the last dialysis session of each treatment period (i.e. 5 times in total) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 4 hours (=one dialysis treatment); assessed during all dialysis sessions (12 treatments per intervention, measured 4x/hour) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Muriel PC Grooteman, MD PhD | Contact | +3120 566 5990 | mpc.grooteman@amsterdamumc.nl | |
| Sabrine Chaara, MD | Contact | +316463173499 | s.chaara@amsterdamumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Muriel PC Grooteman, MD PhD | Amsterdam UMC | Principal Investigator |
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Randomized cross-over trial
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| High volume hemodiafiltration (DNa<PNa) | Active Comparator | High volume hemodiafiltration with expected diffusive sodium efflux (DNa\ |
|
| Hemodialysis (DNa<PNa) | Device | High-flux hemodialysis with expected diffusive sodium efflux (DNa\ |
|
| 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\ |
|
| Change in intradialytic blood pressure |
Change in systolic and diastolic blood pressure (mmHg) during one dialysis session |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 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. | 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. | 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. | 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. | up to 20 weeks; evaluated every 4 weeks, during/after the last dialysis session of each treatment period |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D006435 | Renal Dialysis |
| ID | Term |
|---|---|
| D017582 | Renal Replacement Therapy |
| D013812 | Therapeutics |
| D016060 | Sorption Detoxification |
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