Urea for Treatment of Hyponatremia in Patients With SIAD Unresponsive to Fluid Restriction
Recruiting now · Not applicable
Conditions studied: SIAD - Syndrome of Inappropriate Antidiuresis
In brief
Hyponatremia due to SIAD is frequently insufficiently corrected by fluid restriction alone, which remains the first-line therapy but is often poorly tolerated. Urea supplementation is recommended as second-line therapy. This prospective study evaluates the effectiveness of oral urea supplementation in patients with chronic SIAD and persistent hyponatremia despite fluid restriction.
Key facts
- Study ID
- NCT07528365
- Run by
- University of Turin, Italy
- People needed
- 20
- Starts
- 2024-09-12
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-04-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Confirmed diagnosis of SIAD established prior to study inclusion, defined as:
- Plasma sodium concentration <135 mmol/L
- Plasma osmolality <300 mOsm/kg
- Urine osmolality >100 mOsm/kg
- Urine sodium concentration >30 mmol/L
- Intact adrenal and thyroidal function and no use of diuretics in the last 4 weeks
- Clinical euvolemia, defined as an absence of signs of hypovolemia (orthostasis, tachycardia, decreased skin turgor, dry mucous membranes) or hypervolemia (edema, ascites)
- Fulfillment of all diagnostic criteria at baseline (day 0) was not mandatory, as the diagnosis of SIAD had already been established prior to study inclusion based on overall clinical assessment.
- Written informed consent obtained
You may not qualify if…
- Chronic hypotonic hyponatremia secondary to another etiology
- Presence of moderate to severe symptoms attributable to plasma hypotonicity
- Severe hypotonic hyponatremia (serum sodium <120 mmol/L)
- Another ongoing drug treatment for hyponatremia (including vaptans and salt tablets)
- Severe hepatic insufficiency
- eGFR <45 mL/min/1.73 m²
- Pregnancy or breastfeeding
- Known allergy or intolerance to urea
- Patient refusal or inability to provide written informed consent
Where it is running
- AOU Città della Salute e della Scienza — Turin, Piedmont, Italy, Italy (enrolling)
Full record on ClinicalTrials.gov
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