HyponatremiaSyndrome of Inappropriate Antidiuresis
Investigational drug(s) / intervention(s)
Moltein PURE Protein PowderFluid restriction
Moltein PURE Protein Powder: 80 g protein supplementation per day (two bottles, each containing 40 g protein)
Fluid restriction: total daily fluid intake to a maximum of 1000 ml
Study summary
The goal of this study is to assess the impact of protein supplementation on hyponatremia caused by the syndrome of inappropriate antidiuresis during hospitalization.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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%)
Primary outcome measure(s)
Acceptability of Intervention Measure (AIM) questionnaire — 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).
Trial sites (1)
Facility
City
Region
Status
University Hospital Basel
Basel
Switzerland
Recruiting
More University Hospital, Basel, Switzerland trials in Switzerland
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.