RecruitingNot ApplicableNCT06821802

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

Sponsor

University Hospital, Basel, Switzerland

Enrollment

70 participants

Start Date

Apr 14, 2025

Study Type

INTERVENTIONAL

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

Min Age: 18 Years

Inclusion Criteria6

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 Criteria13

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)
Type 1 diabetes or uncontrolled type 2 diabetes (HbA1c >8.0%)

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Interventions

DIETARY_SUPPLEMENTMoltein PURE Protein Powder

80 g protein supplementation per day (two bottles, each containing 40 g protein)

BEHAVIORALFluid restriction

total daily fluid intake to a maximum of 1000 ml

Locations(1)

University Hospital Basel

Basel, Switzerland

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NCT06821802