Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07528365

Urea for Treatment of Hyponatremia in Patients With SIAD Unresponsive to Fluid Restriction

Led by University of Turin, Italy · Updated on 2026-04-14

20

Participants Needed

1

Research Sites

167 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Urea for Treatment of Hyponatremia in Patients With SIAD Unresponsive to Fluid Restriction

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of SIAD before joining the study, including plasma sodium <135 mmol/L
  • Plasma osmolality less than 300 mOsm/kg
  • Urine osmolality greater than 100 mOsm/kg
  • Urine sodium concentration greater than 30 mmol/L
  • Normal adrenal and thyroid function with no diuretic use in the last 4 weeks
  • Clinically euvolemic without signs of low or high blood volume
  • Ability to provide written informed consent
Not Eligible

You will not qualify if you...

  • Chronic hyponatremia due to causes other than SIAD
  • Moderate to severe symptoms caused by low blood sodium
  • Severe hyponatremia with serum sodium below 120 mmol/L
  • Use of other treatments for hyponatremia including vaptans or salt tablets
  • Severe liver failure
  • Estimated glomerular filtration rate below 45 mL/min/1.73 m²
  • Pregnancy or breastfeeding
  • Known allergy or intolerance to urea
  • Inability or refusal to give written informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

AOU Città della Salute e della Scienza

Turin, Piedmont, Italy, Italy, 10126

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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