Effect of Protein Supplementation in Hospitalized Patients With Hyponatremia Due to the Syndrome of Inappropriate Antidiuresis - a Monocentric Randomized Open-label Pragmatic Active-controlled Trial - the TREASUREx Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Acceptability of Intervention Measure (AIM) questionnaire
研究概览
简要总结
The goal of this study is to assess the impact of protein supplementation on hyponatremia caused by the syndrome of inappropriate antidiuresis during hospitalization.
详细描述
Hyponatremia (plasma sodium <135 mmol/L) is the most common electrolyte disorder, affecting up to 30% of hospitalized patients. Chronic hyponatremia (>48 hours) is linked to longer hospital stays, higher costs, increased mortality, and morbidity (e.g., falls, fractures, cognitive deficits). The most common cause of euvolemic hyponatremia is syndrome of inappropriate antidiuresis (SIAD), characterized by excessive water retention due to dysregulated vasopressin activity. Treatment options include fluid restriction or increasing water excretion with AVP antagonists, SGLT2 inhibitors, or oral urea.
A recent trial showed that protein supplementation can induce osmotic diuresis and raise sodium levels similarly to oral urea, with better tolerability. Since protein supplementation is often used in hospitalized patients with malnutrition, this study aims to compare its acceptability to fluid restriction in hospitalized SIAD patients. This head-to-head superiority trial will randomize patients to receive either 80 g of dietary protein daily or fluid restriction (1000 mL/day) for up to 5 days. The hypothesis is that protein supplementation is significantly more acceptable to patients than fluid restriction, ultimately improving treatment outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Adult patients with confirmed SIAD during the hospital stay or at screening, defined by:
- •Plasma sodium concentration <135 mmol/L
- •Plasma osmolality <300 mOsm/kg
- •Urine osmolality >100 mOsm/kg
- •Urine sodium concentration >30 mmol/L
- •Clinical euvolemia (no signs of hypovolemia or hypervolemia)
排除标准
- •Lactose intolerance, milk protein allergy, soy allergy, nuts allergy, or hypersensitivity to components of the protein supplement.
- •Inborn metabolic disorders affecting carbohydrate, lipid, or protein metabolism.
- •Severe symptomatic hyponatremia requiring 3% NaCl or intensive care.
- •New (within the last five days) treatment with SGLT2 inhibitors, vaptans or oral urea
- •Uncontrolled severe hypothyroidism (untreated)
- •Uncontrolled adrenal insufficiency (morning cortisol <150nmol/l)
- •eGFR <45 mL/min/1.73 m² (KDIGO G3b-5) or end-stage renal disease (dialysis)
- •Severe hepatic impairment or advanced symptomatic liver disease defined as past or current hepatic encephalopathy, liver cirrhosis Child C, or decompensated (bleeding, jaundice, hepatorenal syndrome)
- •Pregnancy, breastfeeding, or plans to become pregnant during the study.
- •End-of-life care
- •Lack of capacity or other reasons preventing from giving informed consent or following study procedures (e.g., due to language problems, psychological disorders, dementia, etc.)
- •Treatment with thiazid diuretic (must be stopped at least 48 hours before inclusion)
- •Post-randomization Exclusion Criteria:
- •Type 1 diabetes or uncontrolled type 2 diabetes (HbA1c >8.0%)
结局指标
主要结局
Acceptability of Intervention Measure (AIM) questionnaire
时间窗: On day 5 (or discharge)
Treatment acceptability is assessed using the Acceptability of Intervention Measure (AIM) questionnaire, a validated patient-reported outcome measure scored on a 1 to 5 Likert scale. The total AIM score ranges from 4 to 20, with higher scores indicating greater acceptability. The primary analysis will compare AIM scores between the two treatment groups at the end of the intervention (day 5 or discharge).
次要结局
- Plasma sodium levels(Daily measurements from the day of inclusion to day 5)
- Estimated glomerular filtration rate (eGFR)(On the day of inclusion and on day 5)
- Changes in blood electrolytes(On the day of inclusion and on day 5)
- Changes in urine electrolytes(On the day of inclusion and on day 5)
- Changes in glucose levels(On the day of inclusion and on day 5)
- Changes kidney parameters(On the day of inclusion and on day 5)
- Plasma sodium levels one day after treatment start(On the day of inclusion and 12-36 hours after treatment initiation)
- Endocrine parameters(On the day of inclusion and on day 5)
- Changes in heart rate(On the day of inclusion and on day 5)
- Differences in clinical outcomes - length of hospital stays(Daily from the day of inclusion to day 5)
- General well-being(On the day of inclusion and on day 5)
- Symptoms of hyponatremia(On the day of inclusion and on day 5)
- Fluid intake(Daily measurements from the day of inclusion to day 5)
- Changes in body weight(On the day of inclusion and on day 5)
- Changes in blood pressure(On the day of inclusion and on day 5)
- Need for additional hyponatremia treatment and treatment escalation(Daily from the day of inclusion to day 5)
- Treatment compliance(Daily from the day of inclusion to day 5)
- Quality of life (EQ-5D-5L) questionnaire(On the day of inclusion and on day 5)
- Plasma sodium levels(Daily measurements from the day of inclusion to day 5)
- Estimated glomerular filtration rate (eGFR)(On the day of inclusion and on day 5)
- Changes in blood electrolytes(On the day of inclusion and on day 5)
- Changes in urine electrolytes(On the day of inclusion and on day 5)
- Changes in glucose levels(On the day of inclusion and on day 5)
- Changes kidney parameters(On the day of inclusion and on day 5)
- Plasma sodium levels one day after treatment start(On the day of inclusion and 12-36 hours after treatment initiation)
- Endocrine parameters(On the day of inclusion and on day 5)
- General well-being(On the day of inclusion and on day 5)
- Symptoms of hyponatremia(On the day of inclusion and on day 5)
- Fluid intake(Daily measurements from the day of inclusion to day 5)
- Changes in body weight(On the day of inclusion and on day 5)
- Changes in blood pressure(On the day of inclusion and on day 5)
- Changes in heart rate(On the day of inclusion and on day 5)
- Differences in clinical outcomes - length of hospital stays(Daily from the day of inclusion to day 5)
- Need for additional hyponatremia treatment and treatment escalation(Daily from the day of inclusion to day 5)
- Treatment compliance(Daily from the day of inclusion to day 5)
- Quality of life (EQ-5D-5L) questionnaire(On the day of inclusion and on day 5)