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.
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.
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
Parallel
Hemodialysis or Hemodiafiltration either with sodium zero-diffusive treatment or standard treatment without sodium-control
DevicePatients will be treated for 12 weeks thrice weekly Hemodialysis or Hemodiafiltration sessions resulting in 36 sessions per patient.
Interdialytic weight gain
Evaluation of the impact of sodium zero-diffusive dialysis on interdialytic weight gain will be analyzed in kg and % of dry weight
Intradialytic hemodynamic stability
Evaluation of the impact of sodium zero-diffusive dialysis on intradialytic hemodynamic stability will be analyzed based on frequency of intradialytic hypotensive episodes
Intradialytic hemodynamic stability
Evaluation of the impact of sodium zero-diffusive dialysis on intradialytic hemodynamic stability will be analyzed based on frequency of intradialytic hypertensive episodes
Intradialytic morbid events
Evaluation of the impact of sodium zero-diffusive dialysis on the frequency of intradialytic morbid events will be analyzed
PRO: Thirst feeling
Evaluation of thirst feeling will be assessed via the Dialysis Thirst Inventory
PRO: Thirst feeling
Evaluation of thirst feeling will be assessed via the Xerostomia Inventory
PRO: Fatigue
Evaluation of fatigue will be assessed via the CONVINCE Dialysis Fatigue Scale (CFDS-10)
PRO: Hypotensive episodes
Evaluation of hypotensive episodes will be assessed via the CONVINCE intradialytic symptoms (IDS) Scale - hypotensive episodes items
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