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New treatment option for SIAD - Syndrome of Inappropriate Antidiuresis
Official title Urea for Treatment of Hyponatremia in Patients With SIAD Unresponsive to Fluid Restriction
ClinicalTrials.gov ID: NCT07528365
What this study is testing
- What it's testing
- 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.
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
- 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
You likely can't join 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
See the full eligibility criteria
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Turin, Piedmont, Italy, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 Turin, Piedmont, Italy, Italy. 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.