Comparison of Individualized Sodium Management Versus Standard Treatment in Hemodialysis
NCT ID: NCT06341452
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
130 participants
INTERVENTIONAL
2025-12-16
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Na zero-diffusive treatment
Patients will be treated for 12 weeks sodium zero-diffusive prescription thrice weekly Hemodialysis or Hemodiafiltration sessions resulting in 36 sessions per patient.
Hemodialysis or Hemodiafiltration either with sodium zero-diffusive treatment or standard treatment without sodium-control
Patients will be treated for 12 weeks thrice weekly Hemodialysis or Hemodiafiltration sessions resulting in 36 sessions per patient.
standard treatment without Na-control
Patients will be treated for 12 weeks either with standard dialysate prescription thrice weekly Hemodialysis or Hemodiafiltration sessions resulting in 36 sessions per patient.
Hemodialysis or Hemodiafiltration either with sodium zero-diffusive treatment or standard treatment without sodium-control
Patients will be treated for 12 weeks thrice weekly Hemodialysis or Hemodiafiltration sessions resulting in 36 sessions per patient.
Interventions
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Hemodialysis or Hemodiafiltration either with sodium zero-diffusive treatment or standard treatment without sodium-control
Patients will be treated for 12 weeks thrice weekly Hemodialysis or Hemodiafiltration sessions resulting in 36 sessions per patient.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Fresenius Medical Care Deutschland GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Martin Jirovec, Dr.
Role: PRINCIPAL_INVESTIGATOR
Fresenius Medical Care - DS, s.r.o., Marianske Lazne; Czech Republic
Björn Meijers, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Universitaire Ziekenhuizen Leuven, Leuven, Belgium
Maria Jesus Izquierdo Ortiz, Dr.
Role: PRINCIPAL_INVESTIGATOR
Burgos University Hospital, Burgos, Spain
Locations
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Fresenius Medical Care- DS, s.r.o.
Mariánské Lázně, , Czechia
Countries
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Central Contacts
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Facility Contacts
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Martin Jirovec, Dr.
Role: primary
Other Identifiers
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HD-NaM-01-EU
Identifier Type: -
Identifier Source: org_study_id