Protein supplementation for treating low sodium levels in hospitalized patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University Hospital Basel
  Basel, Switzerland Recruiting

Study contacts

• Principal investigator: Mirjam Christ-Crain, Prof. MD — Universitätsspital Basel
• Study coordinator: Mirjam Christ-Crain, Prof. MD
• Email: mirjam.christ-crain@usb.ch
• Phone: +41 61 328 70 80

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• New diagnostic methods for treating low sodium levels in patients on thiazide diuretics

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• Evaluating electrolyte balance in hyponatremia treatment

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.