[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585009":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":22,"centralContacts":27,"locations":12,"responsibleParty":33,"collaborators":12,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":43,"eligibilityCriteria":44,"healthyVolunteers":39,"sex":45,"minAge":46,"maxAge":12,"enrollmentInfo":47,"targetDuration":12,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":58,"overallStatus":64,"whyStopped":12,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":12},{"fullName":5,"class":6},"Luzerner Kantonsspital","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of care","NO_INTERVENTION","dialysis conducted with standard of care",null,{"label":14,"type":15,"description":14,"interventionNames":16},"dialysis assisted with the sodium management tool","ACTIVE_COMPARATOR",[17],"Other: dialysis assisted with the sodium management tool",[19],{"type":6,"name":14,"description":20,"armGroupLabels":21,"otherNames":12},"Sodium management tool is a modul of the fresenius 6008 dialysis machine. This model approximates changes in plasma electrolyte concentrations during dialysis and allows the estimation of sodium concentration based on dialysate conductivity. Na control biosensor continuously (every minute) monitors the dialysate side sodium balance based on measurements of fresh and spent dialysate conductivities and the application of a kinetic model to account for the typical influence of other ions on dialysate conductivity. In activated Na control, as \"zero diffusive\" mode, dialysate sodium is then adjusted continuously to minimize diffusive Na transfer. SMT is part of the 6008 Machine and its certification is included in the Fresenius 6008 Machine certification. Untill now there is no data if this modul benefits. in this study the investigator compares standard of care dialysis (Arm 1) with dialysis assisted with the SMT (Arm ) on clinical outcome",[14],[23],{"name":24,"affiliation":25,"role":26},"Balthasar Hug, Professor","LUKS Luzern","PRINCIPAL_INVESTIGATOR",[28],{"name":29,"role":30,"phone":31,"phoneExt":12,"email":32},"Sharon-Rose Maloney, MD","CONTACT","+41 412055150","sharon-rose.maloney@luks.ch",{"type":34,"investigatorFullName":35,"investigatorTitle":36,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"SPONSOR_INVESTIGATOR","Sharon-Rose Maloney","MD","100585009","this-study-evaluates-the-impact-of-the-sodium-management-tool-smt-on-hemodialysis-patient-outcomes-compared-to-standard-care-100585009",false,"NCT06896786","This Study Evaluates the Impact of the Sodium Management Tool (SMT) on Hemodialysis Patient Outcomes Compared to Standard Care","Sodium Management Tool in Hemodialysis Patients","SOMEDIA","Inclusion Criteria:\n\n* Outpatients on hemodialysis for at least three months,\n* Dialysis three times a week, age \\>\u002F= 18,\n* dialysis with a Fresenius 6008 Machine,\n* signed informed consent\n\nExclusion:\n\n* Dialysis access with repeated Interruption due to flow problems\n* plasma natrium \\\u003C 130 mmol\u002Fl, \\> 145 mmol\u002Fl, pregnancy -","ALL","18 Years",{"count":48,"type":49},30,"ESTIMATED","INTERVENTIONAL",[52],"NA","Title of the Study: Sodium Management Tool in Hemodialysis Patients\n\nBrief Summary:\n\nThe goal of this clinical trial is to learn whether the Sodium Management Tool (SMT) can improve patients clnical outcomes.\n\nThe main questions this study aims to answer are:\n\nDoes the SMT help reduce weight gain between dialysis sessions? Does the SMT improve dialysis tolerance by reducing symptoms like low blood pressure and muscle cramps?\n\nResearchers will compare standard dialysis to dialysis using the SMT to see if clinical outcomes are better in dialysis that use the SMT.\n\nParticipants will:\n\nReceive dialysis three times per week with either standard dialysis or SMT-activated dialysis Switch between standard dialysis and SMT-activated dialysis after 4 weeks Have their blood pressure, sodium levels, and symptoms monitored during treatment Report their symptoms and thirst levels in a questionnaire Some participants may continue for an additional 4 weeks with a personalized SMT setting based on their symptoms and weight changes.\n\nThis study will help determine whether the SMT can improve sodium balance and make dialysis more comfortable for patients.",[55,56,57],"Hemodialysis","Interdialytic Weight Gain","Intradialytic Hypotension",[59,60,61,62,63],"sodium management in hemodialyis patients","management of complaints in hemodialysis patients","interdialytic weight gain","intradialytic hypotension","sodium management tool","NOT_YET_RECRUITING","2025-03-19",{"date":67,"type":68},"2025-03-26","ACTUAL",{"date":70,"type":49},"2025-04-01",{"date":72,"type":49},"2025-08-31",{"name":35,"class":6}]