Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-27 @ 7:31 AM
Study NCT ID:
NCT06327750
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-25
First Post:
2024-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Microcirculation, Dialysis Modality and Sequestered Salt
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006435', 'term': 'Renal Dialysis'}], 'ancestors': [{'id': 'D017582', 'term': 'Renal Replacement Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D016060', 'term': 'Sorption Detoxification'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized cross-over trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-22', 'studyFirstSubmitDate': '2024-02-21', 'studyFirstSubmitQcDate': '2024-03-22', 'lastUpdatePostDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skin microcirculation', 'timeFrame': 'up to 20 weeks; assessed every 4 weeks before the last dialysis session of each treatment period (i.e. 5 times in total)', 'description': 'Skin microcirculatory perfusion/vasoreactivity (arbitrary units) measured with a laser speckle contrast analysis (LASCA) perfusion imager'}, {'measure': 'Sequestered salt content (SSC)', 'timeFrame': 'up to 20 weeks; assessed every 4 weeks before the last dialysis session of each treatment period (i.e. 5 times in total)', 'description': 'SSC measured with a 7 Tesla 23-Sodium MRI'}], 'secondaryOutcomes': [{'measure': 'Intradialytic hypotension', 'timeFrame': 'up to 4 hours (=one dialysis treatment); assessed during all dialysis sessions (12 treatments per intervention, measured 4x/hour)', 'description': '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.'}, {'measure': 'Change in intradialytic blood pressure', 'timeFrame': 'up to 4 hours (=one dialysis treatment); assessed during all dialysis sessions (12 treatments per intervention, measured 4x/hour)', 'description': 'Change in systolic and diastolic blood pressure (mmHg) during one dialysis session'}, {'measure': 'Peridialytic blood pressure', 'timeFrame': '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)', 'description': 'Change in systolic and diastolic blood pressure (mmHg) between dialysis sessions'}, {'measure': 'Change in CK-MB', 'timeFrame': '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)', 'description': 'Marker of cardiac damage, assessment in blood from arterial line of extracorporeal circuit'}, {'measure': 'Change in high sensitivity C-reactive protein (hs-CRP)', 'timeFrame': '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)', 'description': 'Marker of inflammation, assessment in blood from arterial line of extracorporeal circuit'}, {'measure': 'Change in interleukin-6 receptor (IL-6R)', 'timeFrame': '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)', 'description': 'Marker of inflammation, assessment in blood from arterial line of extracorporeal circuit'}, {'measure': 'Change in soluble CD163 (sCD163)', 'timeFrame': '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)', 'description': 'Marker of inflammation, assessment in blood from arterial line of extracorporeal circuit'}, {'measure': 'Change in soluble intercellular adhesion molecule-1 (s-ICAM-1)', 'timeFrame': '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)', 'description': 'Marker of inflammation, assessment in blood from arterial line of extracorporeal circuit'}, {'measure': 'Change in serum glycosaminoglycans', 'timeFrame': '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)', 'description': 'Marker related to sequestered sodium content, assessment in blood from arterial line of extracorporeal circuit'}, {'measure': 'Change in syndecan-1', 'timeFrame': '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)', 'description': 'Marker related to sequestered sodium content, assessment in blood from arterial line of extracorporeal circuit'}, {'measure': 'Change in vascular endothelial growth factor C (VEGF-C)', 'timeFrame': '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)', 'description': 'Marker related to sequestered sodium content, assessment in blood from arterial line of extracorporeal circuit'}, {'measure': 'Change in extracellular vesicles (EVs)', 'timeFrame': '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)', 'description': 'Marker for tissue-injury and inflammation, assessment in blood from arterial line of extracorporeal circuit'}, {'measure': 'Change in skin microcirculation', 'timeFrame': '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)', 'description': '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.'}, {'measure': 'Change in sequestered salt content (SSC)', 'timeFrame': '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)', 'description': 'Change in SSC measured with a 7 Tesla 23-Sodium MRI during one dialysis session. This will be assessed in 5 patients only.'}, {'measure': 'modified Dialysis symptom index (mDSI)', 'timeFrame': 'up to 20 weeks; evaluated every 4 weeks, during/after the last dialysis session of each treatment period', 'description': "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."}, {'measure': 'Thirst distress scale (TDS)', 'timeFrame': 'up to 20 weeks; evaluated every 4 weeks, during/after the last dialysis session of each treatment period', 'description': "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': 'EQ Visual analogue scale (EQ VAS)', 'timeFrame': 'up to 20 weeks; evaluated every 4 weeks, during/after the last dialysis session of each treatment period', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hemodialysis', 'Hemodiafiltration', 'Microcirculation', 'Sequestered salt content'], 'conditions': ['End-stage Renal Disease']}, 'descriptionModule': {'briefSummary': '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 \\< PNa, difference 3 mmol/L) compared to\n * HD with an expected zero diffusive sodium balance (DNa = PNa) compared to\n * HD with an expected diffusive sodium efflux (DNa \\< PNa, difference 3 mmol/L) 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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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/min\n* Residual diuresis \\<200 ml/day\n* Plasma Na before dialysis 137-145 mmol/L at baseline\n* spKt/Vurea ≥ 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 \\< 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'}, 'identificationModule': {'nctId': 'NCT06327750', 'acronym': 'MIMOSA', 'briefTitle': 'The Microcirculation, Dialysis Modality and Sequestered Salt', 'organization': {'class': 'OTHER', 'fullName': 'Amsterdam UMC, location VUmc'}, 'officialTitle': 'The Microcirculation, Dialysis Modality and Sequestered Salt', 'orgStudyIdInfo': {'id': 'NL83566.018.24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hemodialysis (DNa=PNa)', 'description': 'High-flux hemodialysis with expected diffusive zero sodium balance (DNa=PNa)', 'interventionNames': ['Device: Hemodialysis (DNa<PNa)', 'Device: Hemodialysis after isolated ultrafiltration (DNa=PNa)', 'Device: High volume hemodiafiltration (DNa=PNa)', 'Device: High volume hemodiafiltration (DNa<PNa)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hemodialysis (DNa<PNa)', 'description': 'High-flux hemodialysis with expected diffusive sodium efflux (DNa\\<PNa, difference: 3 mmol/L)', 'interventionNames': ['Device: Hemodialysis (DNa = PNa)', 'Device: Hemodialysis after isolated ultrafiltration (DNa=PNa)', 'Device: High volume hemodiafiltration (DNa=PNa)', 'Device: High volume hemodiafiltration (DNa<PNa)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hemodialysis after isolated ultrafiltration (DNa=PNa)', 'description': 'High-flux hemodialysis after isolated ultrafiltration with expected zero sodium balance (DNa=PNa)', 'interventionNames': ['Device: Hemodialysis (DNa = PNa)', 'Device: Hemodialysis (DNa<PNa)', 'Device: High volume hemodiafiltration (DNa=PNa)', 'Device: High volume hemodiafiltration (DNa<PNa)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High volume hemodiafiltration (DNa=PNa)', 'description': 'High volume hemodiafiltration with expected diffusive zero sodium balance (DNa=PNa)', 'interventionNames': ['Device: Hemodialysis (DNa = PNa)', 'Device: Hemodialysis (DNa<PNa)', 'Device: Hemodialysis after isolated ultrafiltration (DNa=PNa)', 'Device: High volume hemodiafiltration (DNa<PNa)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High volume hemodiafiltration (DNa<PNa)', 'description': 'High volume hemodiafiltration with expected diffusive sodium efflux (DNa\\<PNa, difference: 3 mmol/L)', 'interventionNames': ['Device: Hemodialysis (DNa = PNa)', 'Device: Hemodialysis (DNa<PNa)', 'Device: Hemodialysis after isolated ultrafiltration (DNa=PNa)', 'Device: High volume hemodiafiltration (DNa=PNa)']}], 'interventions': [{'name': 'Hemodialysis (DNa = PNa)', 'type': 'DEVICE', 'description': 'High-flux hemodialysis with an expected zero diffusive sodium balance (DNa = PNa)', 'armGroupLabels': ['Hemodialysis (DNa<PNa)', 'Hemodialysis after isolated ultrafiltration (DNa=PNa)', 'High volume hemodiafiltration (DNa<PNa)', 'High volume hemodiafiltration (DNa=PNa)']}, {'name': 'Hemodialysis (DNa<PNa)', 'type': 'DEVICE', 'description': 'High-flux hemodialysis with expected diffusive sodium efflux (DNa\\<PNa, difference: 3 mmol/L)', 'armGroupLabels': ['Hemodialysis (DNa=PNa)', 'Hemodialysis after isolated ultrafiltration (DNa=PNa)', 'High volume hemodiafiltration (DNa<PNa)', 'High volume hemodiafiltration (DNa=PNa)']}, {'name': 'Hemodialysis after isolated ultrafiltration (DNa=PNa)', 'type': 'DEVICE', 'description': 'High-flux hemodialysis after isolated ultrafiltration with an expected zero diffusive sodium balance (DNa=PNa)', 'armGroupLabels': ['Hemodialysis (DNa<PNa)', 'Hemodialysis (DNa=PNa)', 'High volume hemodiafiltration (DNa<PNa)', 'High volume hemodiafiltration (DNa=PNa)']}, {'name': 'High volume hemodiafiltration (DNa=PNa)', 'type': 'DEVICE', 'description': 'High volume hemodiafiltration with an expected zero diffusive sodium balance (DNa=PNa) Convection volume: ≥23L/session', 'armGroupLabels': ['Hemodialysis (DNa<PNa)', 'Hemodialysis (DNa=PNa)', 'Hemodialysis after isolated ultrafiltration (DNa=PNa)', 'High volume hemodiafiltration (DNa<PNa)']}, {'name': 'High volume hemodiafiltration (DNa<PNa)', 'type': 'DEVICE', 'description': 'High volume hemodiafiltration with expected diffusive sodium efflux (DNa\\<PNa, difference: 3 mmol/L) Convection volume: ≥23L/session', 'armGroupLabels': ['Hemodialysis (DNa<PNa)', 'Hemodialysis (DNa=PNa)', 'Hemodialysis after isolated ultrafiltration (DNa=PNa)', 'High volume hemodiafiltration (DNa=PNa)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Muriel PC Grooteman, MD PhD', 'role': 'CONTACT', 'email': 'mpc.grooteman@amsterdamumc.nl', 'phone': '+3120 566 5990'}, {'name': 'Sabrine Chaara, MD', 'role': 'CONTACT', 'email': 's.chaara@amsterdamumc.nl', 'phone': '+316463173499'}], 'overallOfficials': [{'name': 'Muriel PC Grooteman, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Amsterdam UMC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amsterdam UMC, location VUmc', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dutch Kidney Foundation', 'class': 'OTHER'}, {'name': 'Niercentrum aan de Amstel', 'class': 'UNKNOWN'}, {'name': 'B.Braun Avitum AG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Internist-Nephrologist', 'investigatorFullName': 'Muriel P.C. Grooteman', 'investigatorAffiliation': 'Amsterdam UMC, location VUmc'}}}}