Study Comparing Personalized Sodium Control With Standard Treatment in Hemodialysis for Kidney Failure

What this Trial Is About

Researchers are evaluating the impact of individualized sodium management during hemodialysis compared to standard treatment for patients with end stage renal disease on dialysis. The study aims to assess differences in fluid control, weight gain between dialysis sessions, blood pressure stability during treatment, and the rate of adverse events occurring during dialysis. Quality of life and overall wellbeing of patients will also be monitored to understand the effects of sodium control in this setting. Participants will be randomly assigned to one of two groups one receiving hemodialysis or hemodiafiltration with a sodium zero-diffusive treatment setting enabled on the dialysis machine, and the other receiving standard dialysis treatment without sodium control. Each patient will undergo thrice weekly dialysis sessions over a 12-week period, totaling 36 treatments. This approach allows comparison of the sodium management option available on 6008 HD dialysis machines versus the same machines operating without this feature. During the study, researchers will collect clinical data including measurements of fluid status, interdialytic weight gain, hemodynamic stability, and dialysis-related adverse events after 12 weeks of treatment. Patient-reported outcomes such as thirst, fatigue, hypotensive episodes, health-related quality of life, and general health status will also be assessed. Monitoring will ensure safety and collect detailed information about treatment effects over the 12-week trial period.

Comparison of Individualized Sodium Management Versus Standard Treatment in Hemodialysis