Urea for Treatment of Hyponatremia in Patients With SIAD Unresponsive to Fluid Restriction (NCT07528365) | Clinical Trial Compass
RecruitingNot Applicable
Urea for Treatment of Hyponatremia in Patients With SIAD Unresponsive to Fluid Restriction
Italy20 participantsStarted 2024-09-12
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in serum sodium levels
Timeframe: Baseline, day 1, day 21±4, day 42±4, and 10±2 days post urea discontinuation