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New treatment option for Hyponatremia
Official title Protein Supplementation in Hyponatremia Due to the Syndrome of Inappropriate Antidiuresis
ClinicalTrials.gov ID: NCT06821802
What this study is testing
- What it's 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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)
See the full eligibility 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)
- 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%)
The study team makes the final eligibility decision.
Where it's taking place
- Basel, Switzerland
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basel, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.