Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT06821802
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, 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%)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06821802
Study Brief:
Protocol Section:
NCT06821802