[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633567":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":21,"responsibleParty":42,"collaborators":20,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":46,"sex":52,"minAge":53,"maxAge":20,"enrollmentInfo":54,"targetDuration":20,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":24,"whyStopped":20,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"University of Turin, Italy","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Urea therapy","EXPERIMENTAL","Participants will receive oral urea supplementation for 42±4 days, followed by a 10±2-day washout period",[13],"Dietary Supplement: urea",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DIETARY_SUPPLEMENT","urea","Patients with persistent hyponatremia (sodium corrected for glucose \\\u003C135 mmol\u002FL) after ≥1 week of fluid restriction (≤1500 mL\u002Fday) will receive urea 30 g\u002Fday (2 sachets; 1 in the morning and 1 in the evening) dissolved in water, while maintaining fluid restriction ≤1500 mL\u002Fday.\n\nBlood and urine evaluations will be performed at day 1, day 21±4 and day 42±4, with additional assessments (Montreal Cognitive Assessment \\[MoCA\\] questionnaire and bioelectrical impedance vector analysis \\[BIVA\\]) at selected visits.\n\nUrea dose adjustments will be based on serum sodium at day 21±4: 45 g\u002Fday if Na 130-134 mmol\u002FL, or 60 g\u002Fday if Na \\\u003C130 mmol\u002FL (maximum 60 g\u002Fday).\n\nIn case of intolerance, the dose will be reduced by one sachet from the planned dose.\n\nAfter day 42±4, urea will be discontinued. A final evaluation will be performed 10±2 days after discontinuation.",[9],null,[22],{"facility":23,"status":24,"city":25,"state":26,"zip":27,"country":28,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":36},"AOU Città della Salute e della Scienza","RECRUITING","Turin","Piedmont, Italy","10126","Italy","IT",{"type":31,"coordinates":32},"Point",[33,34],7.68682,45.07049,{"lat":34,"lon":33},[37],{"name":38,"role":39,"phone":40,"phoneExt":20,"email":41},"Silvia Grottoli, Professor","CONTACT","+390116337400","silvia.grottoli@unito.it",{"type":43,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100633567","urea-for-treatment-of-hyponatremia-in-patients-with-siad-unresponsive-to-fluid-restriction-100633567",false,"NCT07528365","Urea for Treatment of Hyponatremia in Patients With SIAD Unresponsive to Fluid Restriction","Efficacy of Oral Urea Supplementation in Patients With SIAD Not Adequately Controlled With Fluid Restriction","UREA-BIVA","Inclusion Criteria:\n\n* Confirmed diagnosis of SIAD established prior to study inclusion, defined as:\n* Plasma sodium concentration \\\u003C135 mmol\u002FL\n* Plasma osmolality \\\u003C300 mOsm\u002Fkg\n* Urine osmolality \\>100 mOsm\u002Fkg\n* Urine sodium concentration \\>30 mmol\u002FL\n* Intact adrenal and thyroidal function and no use of diuretics in the last 4 weeks\n* Clinical euvolemia, defined as an absence of signs of hypovolemia (orthostasis, tachycardia, decreased skin turgor, dry mucous membranes) or hypervolemia (edema, ascites)\n\nFulfillment 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.\n\n\\- Written informed consent obtained\n\nExclusion Criteria:\n\n* Chronic hypotonic hyponatremia secondary to another etiology\n* Presence of moderate to severe symptoms attributable to plasma hypotonicity\n* Severe hypotonic hyponatremia (serum sodium \\\u003C120 mmol\u002FL)\n* Another ongoing drug treatment for hyponatremia (including vaptans and salt tablets)\n* Severe hepatic insufficiency\n* eGFR \\\u003C45 mL\u002Fmin\u002F1.73 m²\n* Pregnancy or breastfeeding\n* Known allergy or intolerance to urea\n* Patient refusal or inability to provide written informed consent","ALL","18 Years",{"count":55,"type":56},20,"ESTIMATED","INTERVENTIONAL",[59],"NA","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.\n\nThis prospective study evaluates the effectiveness of oral urea supplementation in patients with chronic SIAD and persistent hyponatremia despite fluid restriction.",[62],"SIAD - Syndrome of Inappropriate Antidiuresis",[64,17,65,66],"hyponatremia","plasma sodium level","SIAD","2026-04-07",{"date":69,"type":70},"2026-04-14","ACTUAL",{"date":72,"type":70},"2024-09-12",{"date":74,"type":56},"2027-12",{"name":5,"class":6},1]