Clinical Trial

This Study Evaluates the Impact of the Sodium Management Tool (SMT) on Hemodialysis Patient Outcomes Compared to Standard Care

Study acronym: SOMEDIA
Not Yet Recruiting
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Record status
This record was last updated March 26, 2025 (before its estimated August 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
Title of the Study: Sodium Management Tool in Hemodialysis Patients Brief Summary: The goal of this clinical trial is to learn whether the Sodium Management Tool (SMT) can improve patients clnical outcomes. The main questions this study aims to answer are: Does the SMT help reduce weight gain between dialysis sessions? Does the SMT improve dialysis tolerance by reducing symptoms like low blood pressure and muscle cramps? Researchers will compare standard dialysis to dialysis using the SMT to see if clinical outcomes are better in dialysis that use the SMT. Participants will: Receive dialysis three times per week with either standard dialysis or SMT-activated dialysis Switch between standard dialysis and SMT-activated dialysis after 4 weeks Have their blood pressure, sodium levels, and symptoms monitored during treatment Report their symptoms and thirst levels in a questionnaire Some participants may continue for an additional 4 weeks with a personalized SMT setting based on their symptoms and weight changes. This study will help determine whether the SMT can improve sodium balance and make dialysis more comfortable for patients.
Trial Details
NCT Number NCT06896786
Lead Sponsor Sharon-Rose Maloney
Conditions Hemodialysis, Interdialytic Weight Gain, Intradialytic Hypotension
Enrollment 30 participants
Start Date 2025-04-01
Primary Completion 2025-08-31 (estimated)
Study Completion 2025-08-31 (estimated)
Updated on ClinicalTrials.gov 2025-03-26