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Protein Supplementation in Hyponatremia Due to the Syndrome of Inappropriate Antidiuresis

RECRUITINGN/ASponsored by University Hospital, Basel, Switzerland
Actively Recruiting
PhaseN/A
SponsorUniversity Hospital, Basel, Switzerland
Started2025-04-14
Est. completion2027-04
Eligibility
Age18 Years+
Healthy vol.Accepted

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

Age: 18 Years+Healthy volunteers accepted
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%)

Conditions3

DiabetesHyponatremiaSyndrome of Inappropriate Antidiuresis

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