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RECRUITING
NCT06341452
NA

Comparison of Individualized Sodium Management Versus Standard Treatment in Hemodialysis

Sponsor: Fresenius Medical Care Deutschland GmbH

View on ClinicalTrials.gov

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

Interventions

DEVICE

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