Comparison of Individualized Sodium Management Versus Standard Treatment in Hemodialysis

Sponsor
Fresenius Medical Care Deutschland GmbH
Study ID
NCT06341452
Status
Recruiting
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Conditions

  • End Stage Renal Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hemodialysis or Hemodiafiltration either with sodium zero-diffusive treatment or standard treatment without sodium-control — DEVICE
    Patients will be treated for 12 weeks thrice weekly Hemodialysis or Hemodiafiltration sessions resulting in 36 sessions per patient.

Study Details

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 Dates

First listed
Apr 2, 2024
Start date
Dec 16, 2025
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
130 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Na zero-diffusive treatment
    Patients will be treated for 12 weeks sodium zero-diffusive prescription thrice weekly Hemodialysis or Hemodiafiltration sessions resulting in 36 sessions per patient.
  • Other: standard treatment without Na-control
    Patients will be treated for 12 weeks either with standard dialysate prescription thrice weekly Hemodialysis or Hemodiafiltration sessions resulting in 36 sessions per patient.

Primary Outcome Measure

Interdialytic weight gain [ Time Frame: 12 weeks after start of study ]

Central Contacts

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