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Comparison of Individualized Sodium Management Versus Standard Treatment in Hemodialysis
Sponsor: Fresenius Medical Care Deutschland GmbH
Summary
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
130
Start Date
2025-12-16
Completion Date
2026-12
Last Updated
2025-12-22
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
Fresenius Medical Care- DS, s.r.o.
Mariánské Lázně, Czechia