NCT06821802·Not applicable·INTERVENTIONAL

Protein Supplementation in Hyponatremia Due to the Syndrome of Inappropriate Antidiuresis

Vasopressin Other Recruiting

Status

Recruiting

Phase

Not applicable

Enrollment

Locations

Results

Not posted

Publications

Study summary

What the protocol is testing.

The goal of this study is to assess the impact of protein supplementation on hyponatremia caused by the syndrome of inappropriate antidiuresis during hospitalization.

Full detailed description

Hyponatremia (plasma sodium \<135 mmol/L) is the most common electrolyte disorder, affecting up to 30% of hospitalized patients. Chronic hyponatremia (\>48 hours) is linked to longer hospital stays, higher costs, increased mortality, and morbidity (e.g., falls, fractures, cognitive deficits). The most common cause of euvolemic hyponatremia is syndrome of inappropriate antidiuresis (SIAD), characterized by excessive water retention due to dysregulated vasopressin activity. Treatment options include fluid restriction or increasing water excretion with AVP antagonists, SGLT2 inhibitors, or oral urea. A recent trial showed that protein supplementation can induce osmotic diuresis and raise sodium levels similarly to oral urea, with better tolerability. Since protein supplementation is often used in hospitalized patients with malnutrition, this study aims to compare its acceptability to fluid restriction in hospitalized SIAD patients. This head-to-head superiority trial will randomize patients to receive either 80 g of dietary protein daily or fluid restriction (1000 mL/day) for up to 5 days. The hypothesis is that protein supplementation is significantly more acceptable to patients than fluid restriction, ultimately improving treatment outcomes.

Interventions

Treatment arms and agents.

DIETARY_SUPPLEMENT

Moltein PURE Protein Powder

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

BEHAVIORAL

Fluid restriction

total daily fluid intake to a maximum of 1000 ml

Timeline

From registration to results.

First posted
Feb 12, 2025
Study start
Apr 14, 2025
Primary completion
Apr 2027
Study completion
Apr 2027
Results posted
Not reported
Registry updated
Jul 10, 2025

Outcomes

What the study measures.

Primary outcomes

Acceptability of Intervention Measure (AIM) questionnaire

Time frame · On day 5 (or discharge)

Treatment acceptability is assessed using the Acceptability of Intervention Measure (AIM) questionnaire, a validated patient-reported outcome measure scored on a 1 to 5 Likert scale. The total AIM score ranges from 4 to 20, with higher scores indicating greater acceptability. The primary analysis will compare AIM scores between the two treatment groups at the end of the intervention (day 5 or discharge).

Secondary outcomes

Plasma sodium levels

Time frame · Daily measurements from the day of inclusion to day 5

Change in change in plasma sodium levels in mmol/l will be assessed at study inclusion to day 5 of treatment or until discharge

Estimated glomerular filtration rate (eGFR)