RECRUITINGINTERVENTIONAL
Protein Supplementation in Hyponatremia Due to the Syndrome of Inappropriate Antidiuresis
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
About This Trial
The goal of this study is to assess the impact of protein supplementation on hyponatremia caused by the syndrome of inappropriate antidiuresis during hospitalization.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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)
Who Should NOT Join This Trial:
- 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 willing to sign a consent form 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 Who Should NOT Join This Trial:
- Type 1 diabetes or uncontrolled type 2 diabetes (HbA1c \>8.0%)
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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%)
Treatments Being Tested
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
Locations (1)
University Hospital Basel
Basel, Switzerland