MedTrace Logo

Comparison of Individualized Sodium Management Versus Standard Treatment in Hemodialysis

NCT06341452 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2025-12-22

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Fresenius Medical Care Deutschland GmbH

    lead INDUSTRY

Principal Investigators

  • Martin Jirovec, Dr. · Fresenius Medical Care - DS, s.r.o., Marianske Lazne; Czech Republic

  • Björn Meijers, Prof. Dr. · Universitaire Ziekenhuizen Leuven, Leuven, Belgium

  • Maria Jesus Izquierdo Ortiz, Dr. · Burgos University Hospital, Burgos, Spain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-16
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Czechia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06341452 on ClinicalTrials.gov