An interventional study of dialysis assisted with the sodium management tool in Hemodialysis, Interdialytic Weight Gain and Intradialytic Hypotension, sponsored by Luzerner Kantonsspital. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Luzerner Kantonsspital · Not applicable, Interventional, and Treatment
Title of the Study: Sodium Management Tool in Hemodialysis Patients
Brief Summary:
The goal of this clinical trial is to learn whether the Sodium Management Tool (SMT) can improve patients clnical outcomes.
The main questions this study aims to answer are:
Does 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?
Researchers will compare standard dialysis to dialysis using the SMT to see if clinical outcomes are better in dialysis that use the SMT.
Participants will:
Receive 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.
This study will help determine whether the SMT can improve sodium balance and make dialysis more comfortable for patients.
Title of the Study: Sodium Management Tool in Hemodialysis Patients
Objectives This study aims to evaluate the impact of the Sodium Management Tool (SMT) by Fresenius on interdialytic weight gain and dialysis tolerance in hemodialysis patients. While the SMT is already in use across various dialysis centers, there is currently no systematic data collection regarding its clinical benefits.
In conventional hemodialysis, a fixed dialysate sodium concentration (typically 136-138 mmol/L) is used without adjustments during dialysis. If the dialysate sodium concentration is higher than the plasma sodium level, sodium can diffuse into the patient, leading to increased thirst and interdialytic weight gain. These factors are associated with higher mortality and an increased risk of cardiovascular events. Conversely, a negative sodium balance (dialysate sodium concentration lower than plasma sodium) can reduce plasma tonicity, increasing the risk of muscle cramps and intradialytic hypotension.
The SMT continuously measures plasma sodium concentration (once per minute) and adjusts the dialysate sodium concentration. This optimization of sodium homeostasis may reduce the occurrence of muscle cramps and hypotensive episodes during dialysis.
Methods The study will include all outpatient hemodialysis patients from the Lucerne Cantonal Hospital at the Luzern, Luzern Süd, and Sursee sites who undergo dialysis three times per week with Fresenius 6008 machines and have provided informed consent.
Participants will be randomized into two groups:
Group 1: Standard dialysis procedure in weeks 1-4, followed by dialysis with the SMT activated in weeks 5-8. The SMT will be set to 0 mmol/L, meaning the dialysate sodium concentration will be adjusted so that the plasma sodium level at the end of dialysis matches the pre-dialysis level.
Group 2: Dialysis with the SMT activated (Na 0 mmol/L) in weeks 1-4, followed by standard dialysis in weeks 5-8.
Data collection includes:
Interdialytic weight gain Pre- and post-dialysis plasma sodium levels Blood pressure before and after dialysis Bolus administration and total sodium removal Symptomatic hypotension, blood pressure drops >20 mmHg, and muscle cramps (documented by nursing staff) Dialysis tolerance and thirst perception, assessed using a visual analog scale (VAS) Patient-reported symptoms (thirst, shortness of breath, muscle cramps, dizziness, fatigue) using the Dialysis Symptom Index Extension Phase (Weeks 9-12)
For a subset of participants, the study will continue:
Subgroup A: Patients with high interdialytic weight gain will have the SMT set to -1 mmol/L. This setting aims for a plasma sodium level 1 mmol/L lower at the end of dialysis, enhancing sodium removal.
Subgroup B: Patients frequently experiencing symptoms (cramps, hypotension) will have the SMT set to +1 mmol/L. This adjustment targets a plasma sodium level 1 mmol/L higher at the end of dialysis, increasing plasma tonicity.
Outcomes Primary Outcome: Effect of the SMT on interdialytic weight gain. Secondary Outcomes: Incidence of intradialytic hypotension, muscle cramps, and specific patient symptoms (thirst, fatigue, shortness of breath, muscle cramps) measured using the Dialysis Symptom Index.
The study will be conducted in accordance with the Declaration of Helsinki and the International Conference on Harmonization (ICH-GCP) guidelines for Good Clinical Practice. All participants will provide written informed consent. Confidentiality and data protection will be maintained at all times.
885 studies on the registry are indexed under Hypotension; 195 are open to participants now.
This study's enrollment of 36 is below the median of 87 across 590 interventional studies indexed under Hypotension.
Browse Hypotension studies →Luzerner Kantonsspital is the lead sponsor of 62 studies on the registry; 23 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:
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.
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.
dialysis conducted with standard of care
dialysis assisted with the sodium management tool
Other: dialysis assisted with the sodium management tool
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
mean relative interdialytic weight gain (rIDWG)
The primary endpoint is the mean relative interdialytic weight gain (rIDWG) measured in the last week of each study period. Interdialytic weight gain (IDWGt): Weight measured at the beginning of the dialysis at time t minus weight measured after the dialysis at time t-1 (weight pre-dialysis t - weight post-dialysis t-1) Relative interdialytic weight gain (rIDWGt)): Difference of the weight measured at the beginning of the dialysis at time t and the weight measured after the dialysis at time t-1, divided by the weight measured after the dialysis at time t-1 ((weight pre-dialysis t - weight postdialysis t-1) / weight post-dialysis t-1)
Time frame: measured in the last week of each study period (week 4 ,8 ,12)
dialysis tolerance with and without SMT based on dialysis symptom index (DSI)
To assess dialysis tolerance with and without SMT based on PROMs: specific sodium/volume related complaints from the dialysis symptom index (DSI): dry mouth , muscle cramps , dizziness, tiredness , shortness of breath ,VAS Dialysis tolerance , VAS Thirst intensity DSI: For each question, the presence or absence of a specific symptom, as well as its severity, is assessed using a five-point Likert scale, with each response ranging from 0 to 4 (i.e., a response of "0" indicates "no," whereas a response of "4" indicates "yes: very much")
Time frame: measured in the last week of each study period (week 4, 8 and 12)
dialysis tolerance with and without SMT based on Visual Analogue Scale (VAS ) Dialysis tolerance:
To assess dialysis tolerance with and without SMT based on VAS for Dialysis tolerance VAS Dialyse tolerance: Patients will be requested to rate their dialysis experience on a 10-cm VAS, where 0 is the worst imaginable dialysis experience and 10 the best imaginable dialysis experience.
Time frame: measured in the last week of each study period (week 4, 8 and 12)
Thirst Intensity with and without SMT based on VAS thirst intensity
To assess thirst intensity with and without SMT based on VAS for thirst intensity VAS thirst intensity: Patients will be requested to rate their thirst since the last dialysis on a 10-cm VAS, with 0 indicating no thirst and 10 indicating the worst possible thirst.
Time frame: measured in the last week of each study period (week 4, 8 and 12)
Plan to share: No
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Ran from Jan 2026 to primary completion in Aug 2026, 7 months.
Of 210 non-industry interventional studies with no phase under Hypotension, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 22. This study's 7 months is below that.
Counting every sponsor, half of 217 studies reached it within 12 months; a quarter within 6 and three quarters within 22.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 21, 2026: start Apr 2025 → Jan 2026, primary completion Aug 2025 → Aug 2026 and completion Aug 2025 → Aug 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Luzerner Kantonsspital