Protein Supplementation in Hyponatremia Due to the Syndrome of Inappropriate Antidiuresis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Basel, Switzerland
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Plasma sodium concentration <135 mmol/L
Plasma osmolality <300 mOsm/kg
Urine osmolality >100 mOsm/kg
Urine sodium concentration >30 mmol/L
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Moltein PURE Protein Powder
Dietary supplement80 g protein supplementation per day (two bottles, each containing 40 g protein)
Fluid restriction
Behavioraltotal daily fluid intake to a maximum of 1000 ml
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Protein SupplementationExperimental treatment 1 intervention
Group B: Fluid restrictionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Acceptability of Intervention Measure (AIM) questionnaire
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).
Time frame
On day 5 (or discharge)Secondary outcomes
1
Plasma sodium levels
Change in change in plasma sodium levels in mmol/l will be assessed at study inclusion to day 5 of treatment or until discharge
Time frame
Daily measurements from the day of inclusion to day 52
Estimated glomerular filtration rate (eGFR)
Assessement of creatinine levels
Time frame
On the day of inclusion and on day 53
Changes in blood electrolytes
Assessement of sodium levels
Time frame
On the day of inclusion and on day 54
Changes in urine electrolytes
Assessement of sodium levels
Time frame
On the day of inclusion and on day 5Sponsors and contacts
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Source ClinicalTrials.gov