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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
Patients will be treated for 12 weeks thrice weekly Hemodialysis or Hemodiafiltration sessions resulting in 36 sessions per patient.
Fresenius Medical Care- DS, s.r.o.
Mariánské Lázně, Czechia
RECRUITINGInterdialytic weight gain
Evaluation of the impact of sodium zero-diffusive dialysis on interdialytic weight gain will be analyzed in kg and % of dry weight
Time frame: 12 weeks after start of study
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
Time frame: 12 weeks after start of study
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
Time frame: 12 weeks after start of study
Intradialytic morbid events
Evaluation of the impact of sodium zero-diffusive dialysis on the frequency of intradialytic morbid events will be analyzed
Time frame: 12 weeks after start of study
Fluid status
Evaluation of the impact of sodium zero-diffusive dialysis on fluid status will be analyzed with regard to overhydration (L)
Time frame: 12 weeks after start of study
Fluid status
Evaluation of the impact of sodium zero-diffusive dialysis on fluid status will be analyzed with regard to dry weight (kg)
Time frame: 12 weeks after start of study
PRO: Thirst feeling
Evaluation of thirst feeling will be assessed via the Dialysis Thirst Inventory
Time frame: 12 weeks after start of study
PRO: Thirst feeling
Evaluation of thirst feeling will be assessed via the Xerostomia Inventory
Time frame: 12 weeks after start of study
PRO: Fatigue
Evaluation of fatigue will be assessed via the CONVINCE Dialysis Fatigue Scale (CFDS-10)
Time frame: 12 weeks after start of study
PRO: Hypotensive episodes
Evaluation of hypotensive episodes will be assessed via the CONVINCE intradialytic symptoms (IDS) Scale - hypotensive episodes items
Time frame: 12 weeks after start of study
PRO: HRQOL
Evaluation of health related quality of life (HRQOL) will be assessed using the validated Kidney Disease Quality of Life (KDQOL) survey KDQOL-36
Time frame: 12 weeks after start of study
PRO: Health status
Evaluation of health status will be assessed via the validated EQ-5D-5L survey by EuroQol group
Time frame: 12 weeks after start of study
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