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.
Outpatients on hemodialysis for at least three months,
Dialysis three times a week, age >/= 18,
dialysis with a Fresenius 6008 Machine,
signed informed consent
None
Crossover
dialysis assisted with the sodium management tool
Other interventionSodium management tool is a modul of the fresenius 6008 dialysis machine. This model approximates changes in plasma electrolyte concentrations during dialysis and allows the estimation of sodium concentration based on dialysate conductivity. Na control biosensor continuously (every minute) monitors the dialysate side sodium balance based on measurements of fresh and spent dialysate conductivities and the application of a kinetic model to account for the typical influence of other ions on dialysate conductivity. In activated Na control, as "zero diffusive" mode, dialysate sodium is then adjusted continuously to minimize diffusive Na transfer. SMT is part of the 6008 Machine and its certification is included in the Fresenius 6008 Machine certification. Untill now there is no data if this modul benefits. in this study the investigator compares standard of care dialysis (Arm 1) with dialysis assisted with the SMT (Arm ) on clinical outcome
mean relative interdialytic weight gain (rIDWG)
The primary endpoint is the mean relative interdialytic weight gain (rIDWG) measured in the last week of each study period. Interdialytic weight gain (IDWGt): Weight measured at the beginning of the dialysis at time t minus weight measured after the dialysis at time t-1 (weight pre-dialysis t - weight post-dialysis t-1) Relative interdialytic weight gain (rIDWGt)): Difference of the weight measured at the beginning of the dialysis at time t and the weight measured after the dialysis at time t-1, divided by the weight measured after the dialysis at time t-1 ((weight pre-dialysis t - weight postdialysis t-1) / weight post-dialysis t-1)
dialysis tolerance with and without SMT based on dialysis symptom index (DSI)
To assess dialysis tolerance with and without SMT based on PROMs: specific sodium/volume related complaints from the dialysis symptom index (DSI): dry mouth , muscle cramps , dizziness, tiredness , shortness of breath ,VAS Dialysis tolerance , VAS Thirst intensity DSI: For each question, the presence or absence of a specific symptom, as well as its severity, is assessed using a five-point Likert scale, with each response ranging from 0 to 4 (i.e., a response of "0" indicates "no," whereas a response of "4" indicates "yes: very much")
dialysis tolerance with and without SMT based on Visual Analogue Scale (VAS ) Dialysis tolerance:
To assess dialysis tolerance with and without SMT based on VAS for Dialysis tolerance VAS Dialyse tolerance: Patients will be requested to rate their dialysis experience on a 10-cm VAS, where 0 is the worst imaginable dialysis experience and 10 the best imaginable dialysis experience.
Thirst Intensity with and without SMT based on VAS thirst intensity
To assess thirst intensity with and without SMT based on VAS for thirst intensity VAS thirst intensity: Patients will be requested to rate their thirst since the last dialysis on a 10-cm VAS, with 0 indicating no thirst and 10 indicating the worst possible thirst.
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Sharon-Rose Maloney
Lead sponsor
Luzerner Kantonsspital
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
