Идёт набор NCT06821802

Protein Supplementation in Hyponatremia Due to the Syndrome of Inappropriate Antidiuresis

Без фазы С лечением Hyponatremia Syndrome of Inappropriate Antidiuresis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Moltein PURE Protein Powder, Fluid restriction.
Кому может быть актуально: Состояния в реестре: Hyponatremia, Syndrome of Inappropriate Antidiuresis. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Швейцария
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

The goal of this study is to assess the impact of protein supplementation on hyponatremia caused by the syndrome of inappropriate antidiuresis during hospitalization.

Подробное описание

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.

Вмешательства

Пищевая добавка Moltein PURE Protein Powder
80 g protein supplementation per day (two bottles, each containing 40 g protein)
Поведенческое Fluid restriction
total daily fluid intake to a maximum of 1000 ml

Первичные конечные точки

Acceptability of Intervention Measure (AIM) questionnaire [Срок оценки: On day 5 (or discharge)]

Вторичные конечные точки (12)

Plasma sodium levels [Срок оценки: Daily measurements from the day of inclusion to day 5]
Estimated glomerular filtration rate (eGFR) [Срок оценки: On the day of inclusion and on day 5]
Changes in blood electrolytes [Срок оценки: On the day of inclusion and on day 5]
Changes in urine electrolytes [Срок оценки: On the day of inclusion and on day 5]
Changes in glucose levels [Срок оценки: On the day of inclusion and on day 5]
Changes kidney parameters [Срок оценки: On the day of inclusion and on day 5]
Plasma sodium levels one day after treatment start [Срок оценки: On the day of inclusion and 12-36 hours after treatment initiation]
Endocrine parameters [Срок оценки: On the day of inclusion and on day 5]
General well-being [Срок оценки: On the day of inclusion and on day 5]
Symptoms of hyponatremia [Срок оценки: On the day of inclusion and on day 5]
Fluid intake [Срок оценки: Daily measurements from the day of inclusion to day 5]
Changes in body weight [Срок оценки: On the day of inclusion and on day 5]

Критерии участия

Критерии включения

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)

Критерии исключения

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: