New dialysis salt strategy aims to reduce fluid gain and dizziness
NCT ID NCT06341452
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a personalized sodium (salt) management feature on dialysis machines can help people with end-stage kidney disease. It compares the new approach to standard dialysis in 130 adults. The goal is to see if it reduces weight gain between sessions, improves fluid balance, and prevents drops in blood pressure during treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 130 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: General: * Informed consent signed and dated by study patient and authorized physician * Minimum age of 18 years * The patient is legally competent and able to understand the nature, risks, meaning, and consequences of the clinical trial and can subsequently declare her/his consent for participation in the clinical trial * Patients with a chronic kidney disease stage 5D (end stage renal disease with a glomerular filtration rate of 15 ml/min or less) on dialysis as extracorporeal renal replacement therapy. Study-specific: * Patients on dialysis (HD/HDF), at least 4h treatment time thrice weekly ≥ 3 months using a standard dialysate with a prescribed sodium concentration of 136 mmol/L * Anuric patients (\<300mL/d; 1 measurement within last 4 weeks) * Patient fulfils one of the four following criteria: interdialytic weight gain over 4% of dry weight (mean value during run-in period) OR pre-dialytic systolic blood pressure over 180 mmHg (mean value during run-in period) OR intradialytic morbid events (hypotension, hypertension, cramps, headache) in at least three sessions during run-in period OR volume overload according to BCM (FO ≥2.5 L pre-dialysis or relative FO pre-dialysis ≥15% for men and ≥13% for women; one measurement during run-in period) \- Patients with a diffusive Na load of at least 1 mmoL/(L TBW) or 0.06g NaCl/(L TBW) (mean value during the run-in period). Exclusion Criteria: General: * Any conditions which could interfere with the patient's ability to comply with the study * Patient is not able to give informed consent according to European Medical Device Regulation and corresponding national regulations * In case of female patients: pregnancy (pregnancy test will be conducted at start and end of study with female patients aged ≤55 years) or lactation period * Participation in an interventional clinical study during the preceding 30 days * Previous participation in the same study Study-specific: * Patients treated with individualized sodium management over the last 3 months * Severe hypoalbuminemia (≤30 g/L; 1 measurement within last 4 weeks) * Hypernatremia (pre-dialytic plasma sodium concentration ≥145mmol/L; 1 measurement within last 4 weeks) * Uncontrolled diabetic patients with glycated hemoglobin (HbA1C) \>8%; 1 measurement within last 4 weeks * Impossible reliable measurement of the different compartments by bioimpedance due to lower limb amputation or wearing of a unipolar pacemaker or metallic prostheses * Life expectancy less than 6 months * ONLINEplus HF treatments/hemofiltration treatments * Single-needle treatments * Dry weight \< 40kg * Active or chronic infections (HIV, SARS-CoV-2, HBV, HCV)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fresenius Medical Care- DS, s.r.o.
RECRUITINGMariánské Lázně, 35301, Czechia
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Other studies related to the condition(s) this trial covers.
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