HemodialysisSOMADIANCT06896786
This Study Evaluates the Impact of the Sodium Management Tool (SMT) on Hemodialysis Patient Outcomes Compared to Standard Care
A study testing dialysis assisted with the sodium management tool in people with Hemodialysis and Interdialytic Weight Gain, run by Luzerner Kantonsspital at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis, Interdialytic Weight Gain, Intradialytic Hypotension
- What is being tested?
- dialysis assisted with the sodium management tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Jan 2026to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients on hemodialysis for at least three months,
- Dialysis three times a week, age >/= 18,
- dialysis with a Fresenius 6008 Machine,
- signed informed consent
Who cannot join
- Dialysis access with repeated Interruption due to flow problems
- plasma natrium < 130 mmol/l, > 145 mmol/l, pregnancy -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sodium Management Tool in Hemodialysis Patients
Title of the Study: Sodium Management Tool in Hemodialysis Patients
Brief Summary:
Read more
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.
Read the detailed description
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.
- Being tested
- dialysis assisted with the sodium management tool
- Keywords
- sodium management in hemodialyis patients, management of complaints in hemodialysis patients, interdialytic weight gain, intradialytic hypotension, sodium management tool
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dialysis assisted with the sodium management toolOther
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
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | dialysis conducted with standard of care |
| dialysis assisted with the sodium management tool | Active comparator | dialysis assisted with the sodium management tool Receives: Other: dialysis assisted with the sodium management tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: measured in the last week of each study period (week 4 ,8 ,12)
Secondary outcomes (3)
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")
Measured: 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.
Measured: 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.
Measured: measured in the last week of each study period (week 4, 8 and 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start2 Jan 2026
- Primary completion31 Aug 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- randomised, cross over , single site design
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luzerner Kantonsspital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sharon-Rose Maloney, Luzerner Kantonsspital
- Investigators
- Balthasar Hug, Professor, Principal investigator, LUKS Luzern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06896786
- Sponsor's protocol ID
- NEP-LU-0001
- Acronym
- SOMADIA
- Status last verified
- Jan 2026
- First submitted
- 9 Feb 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium Management Tool in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT06896786
- Acronym / sponsor ID
- SOMADIA / NEP-LU-0001
- Keywords
- sodium management in hemodialyis patients, management of complaints in hemodialysis patients, interdialytic weight gain, intradialytic hypotension, sodium management tool
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Luzerner KantonsspitalUniversity, hospital or other
- Study start
- 2 Jan 2026 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomised, cross over , single site design
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –dialysis conducted with standard of care |
| dialysis assisted with the sodium management tool | Active comparator | Other: dialysis assisted with the sodium management tooldialysis assisted with the sodium management tool |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Outpatients on hemodialysis for at least three months,
- Dialysis three times a week, age >/= 18,
- dialysis with a Fresenius 6008 Machine,
- signed informed consent
Key exclusion criteria (2 listed)
- Dialysis access with repeated Interruption due to flow problems
- plasma natrium < 130 mmol/l, > 145 mmol/l, pregnancy -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dialysis assisted with the sodium management toolSodium 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 | Other | dialysis assisted with the sodium management tool |
Primary outcome
mean relative interdialytic weight gain (rIDWG)
Time frame: measured in the last week of each study period (week 4 ,8 ,12)
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)
3 secondary outcomes
dialysis tolerance with and without SMT based on dialysis symptom index (DSI)
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:
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
Time frame: measured in the last week of each study period (week 4, 8 and 12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Balthasar Hug, Professor principal investigator
LUKS Luzern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dialysis assisted with the sodium management tool in people with Hemodialysis and Interdialytic Weight Gain, run by Luzerner Kantonsspital at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean relative interdialytic weight gain (rIDWG) (time frame: measured in the last week of each study period (week 4 ,8 ,12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.