Protein Supplementation in Hyponatremia Due to the Syndrome of Inappropriate Antidiuresis

Launched by UNIVERSITY HOSPITAL, BASEL, SWITZERLAND · Feb 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how protein supplementation might help patients with hyponatremia, a condition where sodium levels in the blood are too low, caused by the syndrome of inappropriate antidiuresis (SIAD). This condition can happen during hospital stays, and the researchers want to see if adding more protein to the diet can improve sodium levels. The study is currently looking for adult participants, aged 65 to 74, who have confirmed SIAD, which is identified by specific blood and urine tests indicating low sodium levels and other related factors.

To be eligible for the trial, participants must not have certain health issues like severe kidney or liver problems, or allergies to milk or soy products. They also should not be pregnant or breastfeeding. If you join the study, you can expect to receive protein supplements during your hospital stay and participate in regular assessments to monitor your sodium levels and overall health. This research could provide valuable insights into new treatments for hyponatremia, potentially improving care for patients with this condition.

Gender

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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, celiac disease, 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.
• • Type 1 diabetes or uncontrolled type 2 diabetes (HbA1c \>8.0%).
• • Uncontrolled severe hypothyroidism or adrenal insufficiency.
• • eGFR \<60 mL/min/1.73 m² (KDIGO G3-5) or end-stage renal disease.
• • Severe hepatic impairment or advanced symptomatic liver disease.
• • New (within the last five days) treatment with diuretics, SGLT2 inhibitors, lithium, urea, vaptans
• • Pregnancy, breastfeeding, or plans to become pregnant during the study.
• • End-of-life care, current participation in another intervention study, or inability to give informed consent or follow study procedures.