Protein Supplementation in Hyponatremia Due to the Syndrome of Inappropriate Antidiuresis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Moltein PURE Protein Powder, Fluid restriction.
- Who it may be relevant to
- Registry conditions: Hyponatremia, Syndrome of Inappropriate Antidiuresis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
The goal of this study is to assess the impact of protein supplementation on hyponatremia caused by the syndrome of inappropriate antidiuresis during hospitalization.
Detailed description
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.
Interventions
- Dietary supplement Moltein PURE Protein Powder
80 g protein supplementation per day (two bottles, each containing 40 g protein) - Behavioral Fluid restriction
total daily fluid intake to a maximum of 1000 ml
Primary outcome measures
- Acceptability of Intervention Measure (AIM) questionnaire [Time frame: On day 5 (or discharge)]
Secondary outcome measures (12)
- Plasma sodium levels [Time frame: Daily measurements from the day of inclusion to day 5]
- Estimated glomerular filtration rate (eGFR) [Time frame: On the day of inclusion and on day 5]
- Changes in blood electrolytes [Time frame: On the day of inclusion and on day 5]
- Changes in urine electrolytes [Time frame: On the day of inclusion and on day 5]
- Changes in glucose levels [Time frame: On the day of inclusion and on day 5]
- Changes kidney parameters [Time frame: On the day of inclusion and on day 5]
- Plasma sodium levels one day after treatment start [Time frame: On the day of inclusion and 12-36 hours after treatment initiation]
- Endocrine parameters [Time frame: On the day of inclusion and on day 5]
- General well-being [Time frame: On the day of inclusion and on day 5]
- Symptoms of hyponatremia [Time frame: On the day of inclusion and on day 5]
- Fluid intake [Time frame: Daily measurements from the day of inclusion to day 5]
- Changes in body weight [Time frame: On the day of inclusion and on day 5]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- 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%)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Switzerland · 1 center
- University Hospital Basel — Basel
Identifiers
NCT: NCT06821802 · 2024-02282; kt25ChristCrain2