Protein supplementation for treating low sodium levels in hospitalized patients

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

This study is testing if giving extra protein to hospitalized patients with low sodium levels works better and is more acceptable than limiting their fluid intake.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Basel, Switzerland (other)
• Locations: 1 site (Basel)
• Trial ID: NCT06821802 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of protein supplementation in patients with hyponatremia caused by the syndrome of inappropriate antidiuresis (SIAD) during their hospital stay. It aims to compare the acceptability and outcomes of providing 80 grams of dietary protein daily against a fluid restriction of 1000 mL per day over a period of up to 5 days. The hypothesis is that protein supplementation will be more acceptable and beneficial for patients than fluid restriction, potentially improving sodium levels and overall treatment outcomes. The study will involve randomization of eligible patients to receive either intervention.

Who should consider this trial

Good fit: Ideal candidates are adult patients hospitalized with confirmed SIAD and low plasma sodium levels.

Not a fit: Patients with severe symptomatic hyponatremia or significant comorbidities affecting metabolism may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a more tolerable and effective treatment option for patients with hyponatremia.

How similar studies have performed: Previous studies have indicated that protein supplementation can effectively raise sodium levels, suggesting potential success for this approach.

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%)

Where this trial is running

Basel

• University Hospital Basel — Basel, Switzerland (RECRUITING)

Study contacts

• Principal investigator: Mirjam Christ-Crain, Prof. MD — Universitätsspital Basel
• Study coordinator: Mirjam Christ-Crain, Prof. MD

Conditions: Hyponatremia, Syndrome of Inappropriate Antidiuresis, dysregulated arginine vasopressin secretion, increased renal AVP sensitivity, protein supplementation, fluid restriction