Sodium Management Tool in Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- mean relative interdialytic weight gain (rIDWG)
研究概览
简要总结
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.
详细描述
Title of the Study: Sodium Management Tool in Hemodialysis Patients
Objectives This study aims to evaluate the impact of the Sodium Management Tool (SMT) by Fresenius on interdialytic weight gain and dialysis tolerance in hemodialysis patients. While the SMT is already in use across various dialysis centers, there is currently no systematic data collection regarding its clinical benefits.
In conventional hemodialysis, a fixed dialysate sodium concentration (typically 136-138 mmol/L) is used without adjustments during dialysis. If the dialysate sodium concentration is higher than the plasma sodium level, sodium can diffuse into the patient, leading to increased thirst and interdialytic weight gain. These factors are associated with higher mortality and an increased risk of cardiovascular events. Conversely, a negative sodium balance (dialysate sodium concentration lower than plasma sodium) can reduce plasma tonicity, increasing the risk of muscle cramps and intradialytic hypotension.
The SMT continuously measures plasma sodium concentration (once per minute) and adjusts the dialysate sodium concentration. This optimization of sodium homeostasis may reduce the occurrence of muscle cramps and hypotensive episodes during dialysis.
Methods The study will include all outpatient hemodialysis patients from the Lucerne Cantonal Hospital at the Luzern, Luzern Süd, and Sursee sites who undergo dialysis three times per week with Fresenius 6008 machines and have provided informed consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients on hemodialysis for at least three months,
- •Dialysis three times a week, age >/= 18,
- •dialysis with a Fresenius 6008 Machine,
- •signed informed consent
排除标准
- •Dialysis access with repeated Interruption due to flow problems
- •plasma natrium < 130 mmol/l, > 145 mmol/l, pregnancy -
研究组 & 干预措施
Standard of care
dialysis conducted with standard of care
dialysis assisted with the sodium management tool
dialysis assisted with the sodium management tool
干预措施: dialysis assisted with the sodium management tool (Other)
结局指标
主要结局
mean relative interdialytic weight gain (rIDWG)
时间窗: measured in the last week of each study period (week 4 ,8 ,12)
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)
次要结局
- dialysis tolerance with and without SMT based on dialysis symptom index (DSI)(measured in the last week of each study period (week 4, 8 and 12))
- dialysis tolerance with and without SMT based on Visual Analogue Scale (VAS ) Dialysis tolerance:(measured in the last week of each study period (week 4, 8 and 12))
- Thirst Intensity with and without SMT based on VAS thirst intensity(measured in the last week of each study period (week 4, 8 and 12))
研究者
Sharon-Rose Maloney
MD
Luzerner Kantonsspital