NCT06821802 Protein Supplementation in Hyponatremia Due to the Syndrome of Inappropriate Antidiuresis
| NCT ID | NCT06821802 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Basel, Switzerland |
| Condition | Hyponatremia |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-04-14 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2025-04-14 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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%)
Contact & Investigator
Mirjam Christ-Crain, Prof. MD
PRINCIPAL INVESTIGATOR
Universitätsspital Basel
Frequently Asked Questions
Who can join the NCT06821802 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hyponatremia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06821802 currently recruiting?
Yes, NCT06821802 is actively recruiting participants. Contact the research team at mirjam.christ-crain@usb.ch for enrollment information.
Where is the NCT06821802 trial being conducted?
This trial is being conducted at Basel, Switzerland.
Who is sponsoring the NCT06821802 clinical trial?
NCT06821802 is sponsored by University Hospital, Basel, Switzerland. The principal investigator is Mirjam Christ-Crain, Prof. MD at Universitätsspital Basel. The trial plans to enroll 70 participants.