Comparison of Individualized Sodium Management vs. Standard Treatment in Hemodialysis: The SODIAH Study

Abstract

Background: Conventional fluid and sodium (Na) management in dialysis patients includes adjusting dry weight based on clinical judgement and ancillary tools. An innovative approach to optimize Na management during dialysis has been developed with an automated Na control that has been evaluated in proof-of-concept studies (Kuhlmann et al.,2018; Sagova et al., 2019). However, the long-term clinical benefits were not addressed. Recently, Maduell et al. (2023) showed that automated Na control was potentially advantageous in reducing intradialytic weight gain (IDWG), improving blood pressure (BP) control, and decreasing intradialytic serum Na changes. Methods: SODIAH (NCT06341452) is a prospective, parallel, randomized controlled trial with an intervention period of 12 weeks, to be conducted with the 6008 CareSystem (Fresenius Medical Care) in DE, CZ, ES, BE. The study will include 130 anuric HD-patients with a diffusive Na-load during standard dialysis and at least one of the following: IDWG>4% of dry weight, systolic BP (SBP)>180 mmHg, intradialytic morbid events (IMEs), and pre-dialysis fluid overload≥2.5L. To assess variables from patients’ perspective, questionnaires covering fatigue, SBP issues, quality of life, thirst and xerostomia were included. These were translated into the local languages and culturally adapted after cognitive debriefing to ensure accuracy and cultural relevance in the target population. Results: Our study is designed to assess the impact of Na zero-diffusive dialysis on performance indicators, particularly IDWG, intradialytic hemodynamic stability, IMEs, fluid status, and impact on symptom-related well-being of patients. Study results are planned to be reported in 2025. Conclusion: SODIAH aims to broaden the knowledge of Na zero-diffusive dialysis and its clinical benefits. Culturally adapted questionnaires will be available in new languages supporting analysis of symptom-related well-being. Funding: Commercial Support - Fresenius Medical Care