Actively Recruiting
Comparison of Individualized Sodium Management Versus Standard Treatment in Hemodialysis
Led by Fresenius Medical Care Deutschland GmbH · Updated on 2025-12-22
130
Participants Needed
1
Research Sites
50 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The SODIAH study is designed with the aim to assess the impact of isonatremic dialysis on interdialytic weight gain, fluid status, intradialytic hemodynamic stability, and incidence of intradialytic morbid events in dialysis patients. The study will be comparing the Na management option on the 6008 HD dialysis machines with the same machine without the Na management option turned on. Relevant performance and clinical data will be collected as well as information on patients' quality of life and wellbeing.
CONDITIONS
Official Title
Comparison of Individualized Sodium Management Versus Standard Treatment in Hemodialysis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent by the patient and authorized physician
- Age 18 years or older
- Legally competent and able to understand the clinical trial and provide consent
- Diagnosed with chronic kidney disease stage 5D (end stage renal disease) with glomerular filtration rate of 15 ml/min or less and on dialysis
- Receiving hemodialysis or hemodiafiltration treatments at least 4 hours per session, three times weekly for 3 months or longer using a standard dialysate with sodium concentration of 136 mmol/L
- Producing less than 300 mL urine per day (anuric)
- Meet at least one of the following: interdialytic weight gain over 4% of dry weight, pre-dialysis systolic blood pressure over 180 mmHg, intradialytic morbid events in at least three sessions during run-in, or volume overload by bioimpedance criteria
- Having a diffusive sodium load of at least 1 mmoL/(L TBW) or 0.06g NaCl/(L TBW) during run-in period
You will not qualify if you...
- Any condition interfering with ability to comply with the study
- Unable to give informed consent according to regulations
- Pregnancy or lactation in female patients aged 45 years or younger
- Participation in another interventional clinical study within last 30 days
- Previous participation in this study
- Treatment with individualized sodium management in past 3 months
- Severe hypoalbuminemia (≤30 g/L) within last 4 weeks
- Hypernatremia (pre-dialytic plasma sodium ≥145 mmol/L) within last 4 weeks
- Uncontrolled diabetes with HbA1C >8% within last 4 weeks
- Inability to reliably measure compartments by bioimpedance due to limb amputation, pacemaker, or metallic prostheses
- Life expectancy less than 6 months
- Use of ONLINEplus HF or hemofiltration treatments
- Single-needle treatments
- Dry weight less than 40 kg
- Active or chronic infections including HIV, SARS-CoV-2, HBV, or HCV
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fresenius Medical Care- DS, s.r.o.
Mariánské Lázně, Czechia, 35301
Actively Recruiting
Research Team
J
Jennifer Braun, Dr.
CONTACT
M
Manuela Stauss-Grabo, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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