[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100541276":3},{"organization":4,"outcomesModule":7,"designInfo":71,"detailedDescription":80,"studyPopulation":70,"armGroups":81,"interventions":108,"overallOfficials":125,"centralContacts":130,"locations":139,"responsibleParty":176,"collaborators":179,"id":187,"slug":188,"hasResults":189,"nctId":190,"briefTitle":191,"officialTitle":191,"acronym":192,"eligibilityCriteria":193,"healthyVolunteers":189,"sex":194,"minAge":195,"maxAge":70,"enrollmentInfo":196,"targetDuration":70,"studyType":199,"phases":200,"briefSummary":202,"conditions":203,"keywords":205,"overallStatus":142,"whyStopped":70,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":221},{"fullName":5,"class":6},"Amsterdam UMC, location VUmc","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":70},[9],{"measure":10,"description":11,"timeFrame":12},"Sequestered salt content (SSC) in muscle","SSC in muscle tissue 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)",[14,17,20,24,27,31,35,38,40,42,44,47,49,51,54,57,60,64,67],{"measure":15,"description":16,"timeFrame":12},"Sequestered salt content (SSC) in the skin","SSC in the skin measured with a 7 Tesla 23-Sodium MRI",{"measure":18,"description":19,"timeFrame":12},"Skin microcirculation","Skin microcirculatory perfusion\u002Fvasoreactivity (arbitrary units) measured with a laser speckle contrast analysis (LASCA) perfusion imager",{"measure":21,"description":22,"timeFrame":23},"Intradialytic hypotension","A systolic blood pressure (SBP) ≤ 90 mmHg in patients with a pre-dialysis SBP \\\u003C 160 mmHg and a SBP \\\u003C 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\u002Fhour)",{"measure":25,"description":26,"timeFrame":23},"Change in intradialytic blood pressure","Change in systolic and diastolic blood pressure (mmHg) during one dialysis session",{"measure":28,"description":29,"timeFrame":30},"Peridialytic blood pressure","Change in systolic and diastolic blood pressure (mmHg) between dialysis sessions","up to 24 hours (=one interdialytic day): measured 3x\u002Fday every 4 weeks during the last interdialytic day of each treatment period (i.e. 5 times in total)",{"measure":32,"description":33,"timeFrame":34},"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)",{"measure":36,"description":37,"timeFrame":34},"Change in high sensitivity C-reactive protein (hs-CRP)","Marker of inflammation, assessment in blood from arterial line of extracorporeal circuit",{"measure":39,"description":37,"timeFrame":34},"Change in interleukin-6 receptor (IL-6R)",{"measure":41,"description":37,"timeFrame":34},"Change in soluble CD163 (sCD163)",{"measure":43,"description":37,"timeFrame":34},"Change in soluble intercellular adhesion molecule-1 (s-ICAM-1)",{"measure":45,"description":46,"timeFrame":34},"Change in serum glycosaminoglycans","Marker related to sequestered sodium content, assessment in blood from arterial line of extracorporeal circuit",{"measure":48,"description":46,"timeFrame":34},"Change in syndecan-1",{"measure":50,"description":46,"timeFrame":34},"Change in vascular endothelial growth factor C (VEGF-C)",{"measure":52,"description":53,"timeFrame":34},"Change in extracellular vesicles (EVs)","Marker for tissue-injury and inflammation, assessment in blood from arterial line of extracorporeal circuit",{"measure":55,"description":56,"timeFrame":34},"Change in skin microcirculation","Change in skin microcirculatory perfusion\u002Fvasoreactivity (arbitrary units) measured with a laser speckle contrast analysis (LASCA) perfusion imager during one dialysis session. This will be assessed in 5 patients only.",{"measure":58,"description":59,"timeFrame":34},"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.",{"measure":61,"description":62,"timeFrame":63},"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\u002Fafter the last dialysis session of each treatment period",{"measure":65,"description":66,"timeFrame":63},"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.",{"measure":68,"description":69,"timeFrame":63},"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.",null,{"allocation":72,"interventionModel":73,"interventionModelDescription":74,"primaryPurpose":75,"observationalModel":70,"timePerspective":70,"maskingInfo":76},"RANDOMIZED","CROSSOVER","Randomized cross-over trial","TREATMENT",{"masking":77,"maskingDescription":70,"whoMasked":78},"SINGLE",[79],"OUTCOMES_ASSESSOR","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.\n\nTherefore 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.",[82,91,96,100,104],{"label":83,"type":84,"description":85,"interventionNames":86},"Hemodialysis (DNa=PNa)","ACTIVE_COMPARATOR","High-flux hemodialysis with expected diffusive zero sodium balance (DNa=PNa)",[87,88,89,90],"Device: Hemodialysis (DNa\u003CPNa)","Device: Hemodialysis after isolated ultrafiltration (DNa=PNa)","Device: High volume hemodiafiltration (DNa=PNa)","Device: High volume hemodiafiltration (DNa\u003CPNa)",{"label":92,"type":84,"description":93,"interventionNames":94},"Hemodialysis (DNa\u003CPNa)","High-flux hemodialysis with expected diffusive sodium efflux (DNa\\\u003CPNa, difference: 3 mmol\u002FL)",[95,88,89,90],"Device: Hemodialysis (DNa = PNa)",{"label":97,"type":84,"description":98,"interventionNames":99},"Hemodialysis after isolated ultrafiltration (DNa=PNa)","High-flux hemodialysis after isolated ultrafiltration with expected zero sodium balance (DNa=PNa)",[95,87,89,90],{"label":101,"type":84,"description":102,"interventionNames":103},"High volume hemodiafiltration (DNa=PNa)","High volume hemodiafiltration with expected diffusive zero sodium balance (DNa=PNa)",[95,87,88,90],{"label":105,"type":84,"description":106,"interventionNames":107},"High volume hemodiafiltration (DNa\u003CPNa)","High volume hemodiafiltration with expected diffusive sodium efflux (DNa\\\u003CPNa, difference: 3 mmol\u002FL)",[95,87,88,89],[109,114,116,119,122],{"type":110,"name":111,"description":112,"armGroupLabels":113,"otherNames":70},"DEVICE","Hemodialysis (DNa = PNa)","High-flux hemodialysis with an expected zero diffusive sodium balance (DNa = PNa)",[92,97,105,101],{"type":110,"name":92,"description":93,"armGroupLabels":115,"otherNames":70},[83,97,105,101],{"type":110,"name":97,"description":117,"armGroupLabels":118,"otherNames":70},"High-flux hemodialysis after isolated ultrafiltration with an expected zero diffusive sodium balance (DNa=PNa)",[92,83,105,101],{"type":110,"name":101,"description":120,"armGroupLabels":121,"otherNames":70},"High volume hemodiafiltration with an expected zero diffusive sodium balance (DNa=PNa) Convection volume: ≥23L\u002Fsession",[92,83,97,105],{"type":110,"name":105,"description":123,"armGroupLabels":124,"otherNames":70},"High volume hemodiafiltration with expected diffusive sodium efflux (DNa\\\u003CPNa, difference: 3 mmol\u002FL) Convection volume: ≥23L\u002Fsession",[92,83,97,101],[126],{"name":127,"affiliation":128,"role":129},"Muriel PC Grooteman, MD PhD","Amsterdam UMC","PRINCIPAL_INVESTIGATOR",[131,135],{"name":127,"role":132,"phone":133,"phoneExt":70,"email":134},"CONTACT","+3120 566 5990","mpc.grooteman@amsterdamumc.nl",{"name":136,"role":132,"phone":137,"phoneExt":70,"email":138},"Sabrine Chaara, MD","+316463173499","s.chaara@amsterdamumc.nl",[140,159],{"facility":141,"status":142,"city":143,"state":144,"zip":145,"country":146,"countryCode":147,"cosmosGeoPoint":148,"geoPoint":153,"contacts":154},"Niercentrum aan de Amstel (Elyseklinieken)","RECRUITING","Amstelveen","North Holland","1186AM","Netherlands","NL",{"type":149,"coordinates":150},"Point",[151,152],4.86389,52.30083,{"lat":152,"lon":151},[155],{"name":156,"role":132,"phone":157,"phoneExt":70,"email":158},"Fenna G.F. van Breda, MD PhD","+31205669111","g.vanbreda@amsterdamumc.nl",{"facility":160,"status":142,"city":161,"state":144,"zip":162,"country":146,"countryCode":147,"cosmosGeoPoint":163,"geoPoint":167,"contacts":168},"Dianet Amsterdam","Amsterdam","1105 AZ",{"type":149,"coordinates":164},[165,166],4.88969,52.37403,{"lat":166,"lon":165},[169,172],{"name":170,"role":132,"phone":171,"phoneExt":70,"email":134},"Muriel P.C. Grooteman, MD PhD","+312-7320908",{"name":173,"role":132,"phone":174,"phoneExt":70,"email":175},"Lily Jakulj, MD PhD","+31650100023","l.jakulj@amsterdamumc.nl",{"type":129,"investigatorFullName":177,"investigatorTitle":178,"investigatorAffiliation":5,"oldNameTitle":70,"oldOrganization":70},"Muriel P.C. Grooteman","Principal Investigator, Internist-Nephrologist",[180,182,185],{"name":181,"class":6},"Dutch Kidney Foundation",{"name":183,"class":184},"Niercentrum aan de Amstel","UNKNOWN",{"name":186,"class":184},"B Braun Medical supplies trial fluids","100541276","the-microcirculation-dialysis-modality-and-sequestered-salt-100541276",false,"NCT06327750","The Microcirculation, Dialysis Modality and Sequestered Salt","MIMOSA","Inclusion Criteria:\n\n* Age ≥18 years\n* Treatment with HD or HDF 3 x per week during at least 4 hours for at least 3 months\n* Blood flow rate feasiblity of ≥350 ml\u002Fmin\n* Residual diuresis \\\u003C200 ml\u002Fday\n* Plasma Na before dialysis 137-145 mmol\u002FL at baseline\n* spKt\u002FVurea ≥ 1.2\n* Ability to understand study procedures and willingness to provide informed consent\n\nExclusion Criteria:\n\n* Severe incompliance to dialysis procedure and accompanying prescriptions, especially frequency and duration of dialysis treatment\n* Life expectancy \\\u003C 3 months due to non-renal disease\n* Expected transplantation within 6 months\n* Access recirculation \\> 10%\n* Participation in another clinical intervention trial\n* Metal implants (e.g. implantable cardioverter defibrillators)\n* Severe obesity (MRI Ø 60 cm ≈ abdominal circumference ≤ 188 cm)\n* Claustrophobia","ALL","18 Years",{"count":197,"type":198},23,"ESTIMATED","INTERVENTIONAL",[201],"NA","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:\n\n1. What are the effects on the sequestered sodium content and microcirculation after 4 weeks of treatment with the following dialysis modes?\n\n   * HDF with an expected zero diffusive sodium balance (Dialysate sodium concentration (DNa)= Plasma sodium concentration (PNa)) compared to\n   * HDF with an expected diffusive sodium efflux (DNa \\\u003C PNa, difference 3 mmol\u002FL) compared to\n   * HD with an expected zero diffusive sodium balance (DNa = PNa) compared to\n   * HD with an expected diffusive sodium efflux (DNa \\\u003C PNa, difference 3 mmol\u002FL) compared to\n   * Isolated ultrafiltration for 30 minutes followed by HD with an expected zero diffusive sodium balance (DNa = PNa)\n2. Are the SSC and MC interrelated in this patient group?\n\nThis study is a randomized cross-over trial. Participants will be subjected to the abovementioned dialysis treatment modes in random order.",[204],"End-stage Renal Disease",[206,207,208,209,210,211],"Hemodialysis","Hemodiafiltration","Microcirculation","Sequestered salt content","isolated ultrafiltration","dialysate sodium","2026-09-08",{"date":214,"type":215},"2026-09-11","ACTUAL",{"date":217,"type":215},"2026-06-02",{"date":219,"type":198},"2028-05",{"name":5,"class":6},2]