NCT06341452

Comparison of Individualized Sodium Management Versus Standard Treatment in Hemodialysis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Fresenius Medical Care Deutschland GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• End Stage Renal Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-12-16
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-04-02
• Last updated: 2025-12-22

Locations

1 site across 1 country: Czechia