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Comparison of Individualized Sodium Management Versus Standard Treatment in Hemodialysis - Trial NCT06341452

Access comprehensive clinical trial information for NCT06341452 through Pure Global AI's free database. This phase not specified trial is sponsored by Fresenius Medical Care Deutschland GmbH and is currently Not yet recruiting. The study focuses on End Stage Renal Disease. Target enrollment is 130 participants.

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Trial Details
ClinicalTrials.gov โ€ข NCT06341452
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Comparison of Individualized Sodium Management Versus Standard Treatment in Hemodialysis

Study Focus

End Stage Renal Disease

Hemodialysis or Hemodiafiltration either with sodium zero-diffusive treatment or standard treatment without sodium-control

Interventional

device

Sponsor & Location

Fresenius Medical Care Deutschland GmbH

Timeline & Enrollment

N/A

Jun 01, 2024

Dec 01, 2025

130 participants

Primary Outcome

Interdialytic weight gain,Intradialytic hemodynamic stability,Intradialytic hemodynamic stability,Intradialytic morbid events,Fluid status,Fluid status

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.

ICD-10 Classifications

Chronic kidney disease, stage 1
Chronic kidney disease, stage 5
Chronic kidney disease, stage 2
Chronic kidney disease, stage 3
Chronic kidney disease, stage 4

Data Source

ClinicalTrials.gov

NCT06341452

Device Trial