[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hyponatremia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hyponatremia":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,49,74,100,125,149],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100613979","effect-of-protein-supplementation-and-fluid-restriction-on-plasma-sodium-levels-in-patients-undergoing-pituitary-surgery-100613979",false,"NCT07273630","Effect of Protein Supplementation and Fluid Restriction on Plasma Sodium Levels in Patients Undergoing Pituitary Surgery","Effect of Protein Supplementation and Fluid Restriction on Plasma Sodium Levels in Patients Undergoing Pituitary Surgery - a Randomized Open-label Active-controlled Trial -","TREASURE-PIT","Inclusion Criteria:\n\n* Adult patients (aged 18 or older) undergoing trans-sphenoidal or trans-cranial surgery for sellar \u002F suprasellar pathology\n* No pre-existing AVP-deficiency and SIAD or other causes of hyponatremia\n\nExclusion Criteria:\n\n* AVP deficiency diagnosed before surgery based on established criteria\n* Other type of neurosurgery \u002F intracranial pathology \u002F pre-existing spontaneous CSF -rhinorrhea\n* Traumatic brain injury or intracranial hemorrhage\n* Systemic infection or other causes for systemic stress\n* Lactose intolerance, milk protein allergy, soy allergy, nuts allergy or known hypersensitivity or allergy to one of the components of the protein supplementation\n* Inborn metabolic disorders implying carbohydrate, lipid, or protein metabolism\n* Severe hepatic impairment (ALAT\u002FASAT \\>3x upper limit) or advanced symptomatic liver disease defined as past or current hepatic encephalopathy, liver cirrhosis Child C, or decompensated (bleeding, jaundice, hepatorenal syndrome)\n* Reduction of eGFR \\\u003C45 mL\u002Fmin\u002F1.73m² (KDIGO G3b, G4 and G5) or end stage renal disease (dialysis)\n* Recently initiated (within the last 5 days) SGLT2 inhibitors, vaptans, or oral urea therapy\n* Pregnancy or breastfeeding\n* Lack of capacity or other reason preventing from giving informed consent or following study procedures.\n\nPost-Inclusion Exclusion criteria (day 3 post-surgery, i.e.,time of randomization): - AVP deficiency diagnosed on post-operative day 3","ALL","18 Years",{"count":20,"type":21},282,"ESTIMATED","INTERVENTIONAL",[24],"NA","The investigators are conducting this study to investigate new preventive measures for patients with low sodium levels (hyponatremia), which can occur after surgery on the pituitary gland. This hyponatremia is often caused by the syndrome of inappropriate antidiuresis (SIAD). SIAD occurs when the pituitary gland secretes too much antidiuretic hormone. The antidiuretic hormone causes the kidneys to absorb more water. This dilutes the sodium in the blood and leads to hyponatremia. Low sodium levels are particularly common after pituitary surgery, as the procedure on the pituitary gland can lead to increased reactive secretion of antidiuretic hormone. At present, apart from educating patients about the symptoms of hyponatremia, there are no established standard measures for prevention after pituitary surgery. If hyponatremia is present, it is currently treated primarily by fluid restriction, which is not always pleasant or easy to adhere to. With this study, the investigators want to investigate whether protein supplementation or fluid restriction between day 4 and day 9 after surgery can serve as a preventive measure to stabilize sodium levels after pituitary surgery and improve the quality of life of patients.",[27,28],"Hyponatremia","Pituitary Surgery",[30,31,32,33,34,28,35],"postoperative hyponatremia","hyponatremia","SIAD-related complications","protein supplementation","fluid restriction","Plasma Sodium Levels","RECRUITING","2026-02-02",{"date":39,"type":40},"2026-02-03","ACTUAL",{"date":42,"type":40},"2026-01-20",{"date":44,"type":21},"2028-10-01",{"name":46,"class":47},"University Hospital, Basel, Switzerland","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":5},"100396884","phase-4-effects-of-the-sglt2-inhibitor-empagliflozin-in-patients-with-euvolemic-and-hypervolemic-hyponatremia-100396884","NCT04447911","Effects of the SGLT2 Inhibitor Empagliflozin in Patients With Euvolemic and Hypervolemic Hyponatremia","Effects of the SGLT2 Inhibitor Empagliflozin in Patients With Euvolemic and Hypervolemic Hyponatremia - a Multicentric Randomized Double-blind Placebo-controlled Trial (the EMPOWER Study)","EMPOWER","Inclusion Criteria:\n\n\\- chronic eu- OR hypervolemic non hyperosmolar (\\\u003C300 mOsm\u002Fkg) hyponatremia (heparin plasma sodium \\\u003C135 mmol\u002FL on day of inclusion)\n\nExclusion Criteria:\n\n* known hypersensitivity or allergy to class of drugs or the investigational product,\n* severe symptomatic hyponatremia in need of treatment with 3% NaCl-solution or in need of intensive\u002Fintermediate care treatment at time of inclusion\n* clinical hypovolemia\n* Severe reduction of eGFR \\\u003C20 mL\u002Fmin\u002F1,73 m2 (KDIGO G4 and G5) or end stage renal disease\n* Chronic liver insufficiency with Child Pugh Score ≥10 or decompensated liver cirrhosis (jaundice, hepatorenal syndrome, encephalopathy, bleeding, …)\n* Hepatic impairment defined as aspartate transaminase (AST) or alanine transaminase (ALT) \\>3x the upper limit of normal (ULN); or total bilirubin \\>2x ULN at time of enrolment\n* uncontrolled hypothyroidism\n* uncontrolled adrenal insufficiency\n* systolic blood pressure \\\u003C90mmHg\n* contraindication for lowering blood pressure\n* diabetes mellitus type 1 or pancreatic diabetes mellitus\n* treatment with SGLT2 inhibitors, lithium chloride, vaptans, demeclocycline or urea on inclusion day\n* severe immunosuppression (leucocytes \\\u003C2 G\u002Fl)\n* peripheral arterial disease stage III-IV of the Fontaine Classification\n* fasting or other reasons preventing medication intake\n* previous enrolment into the current study\n* participation in another intervention study\n* pregnancy, breastfeeding, intention to become pregnant during the course of the study or lack of safe contraception.\n* end of life care",{"count":58,"type":21},172,[60],"PHASE4","Hyponatremia is the most common electrolyte derangement occurring in hospitalized patients. It is usually classified as hypovolemic, euvolemic or hypervolemic. The most common aetiology of euvolemic hyponatremia is the syndrome of inappropriate antidiuresis (SIAD). Hypervolemic hyponatremia is common in patients with congestive heart failure (CHF) (10-27%) and liver cirrhosis (up to approximately 50%). In SIAD, the regulation of arginine vasopressin (AVP) secretion is impaired which leads to free water retention. In CHF and liver cirrhosis, the effective arterial blood volume is decreased leading to non-osmotic baroreceptor mediated AVP release and consecutive free water retention.\n\nCurrent treatments of euvolemic and hypervolemic hyponatremia, including the most used treatment fluid restriction, are of limited efficacy. Sodium-Glucose-Co-Transporter 2 (SGLT2) inhibitors reduce glucose reabsorption in the proximal tubule, resulting in glucosuria and consecutive osmotic diuresis. A placebo-controlled randomized trial of our group has shown that a short-term, i.e. a 4-days administration of the SGLT2 inhibitor empagliflozin (Jardiance)® in addition to fluid restriction was effective in increasing the serum sodium concentration in 87 patients with SIAD-induced hyponatremia. The effect of empagliflozin (Jardiance)® without additional fluid restriction is however not yet known. Large randomized controlled trials have shown that SGLT2 inhibitors reduced hospitalization for heart failure in patients with, and more recently without type 2 diabetes. No studies have investigated the effect of SGLT2 inhibitors in hypervolemic hyponatremia.\n\nTo evaluate the effect of empagliflozin (Jardiance)® in eu- and hypervolemic hyponatremia, a randomized placebo-controlled study is needed.",[27,63,64,65],"SIADH","Liver Failure","Kidney Failure","2025-11-14",{"date":68,"type":40},"2025-11-17",{"date":70,"type":40},"2021-02-04",{"date":72,"type":21},"2027-02",{"name":46,"class":47},{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":85,"conditions":86,"keywords":87,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":48},"100547446","regulation-of-extracellular-sodium-in-end-stage-renal-disease-upon-volume-and-electrolyte-challenges-100547446","NCT06408077","Regulation of Extracellular Sodium in End Stage Renal Disease Upon Volume and Electrolyte Challenges","Regulation of Extracellular Sodium in End Stage Renal Disease Upon Volume and Electrolyte Challenges - a Prospective Trial.","RESERVE","Inclusion Criteria:\n\n* Adult patients ≥18 years\n* Requirement of renal replacement therapy due to surgical (i.e., nephrectomy) or non-surgical (chronic kidney disease) reason\n* Stable hemodialysis treatment for at least 3 months\n* Urine output \\\u003C100ml in 24 hours\n* Glucose-corrected plasma sodium between 135 mmol\u002Fl and 145 mmol\u002Fl\n* Plasma potassium between 3.5 mmol\u002Fl and 5 mmol\u002Fl\n* Written informed consent\n\nExclusion Criteria:\n\n* Peritoneal dialysis patients\n* Signs of volume expansion or contraction\n* Congestive heart failure (NYHA ≥2)\n* acute illness (infection, congestive heart failure, liver cirrhosis, etc.) requiring hospital admission\n* Uncontrolled arterial hypertension\n* Hemoglobin ≤8g\u002FdL\n* Alcohol abuse\n* Malnutrition\n* Persons, who are in a dependency\u002Femployment relationship with the investigators\n* Accommodation in an institution by judicial or administrative order",{"count":83,"type":21},60,[24],"Hyponatremia is the most common electrolyte disorder of all and can be observed in more than 30% of all patients in hospitals. Osmotic homeostasis of body fluids is essential for survival of all living creatures. It is widely accepted that extra- and intracellular osmolalities are in equilibrium at all times and thus, changes in the extracellular osmolality will lead to either shrinkage or swelling of cells which can be detrimental. In severe cases, it can lead to swelling of the brain and death. Even in less dramatic scenarios, symptoms such as epileptic seizures, headaches, depression and dizziness exist, leading to an increased risk of fractures, hospital admissions and a considerable burden for affected patients.\n\nAs short-term defense against osmotic stress, each individual cell is capable of actively externalizing or internalizing osmotically active solutes which restores normal or near-normal cell volume at the expense of an altered milieu interior. Obviously, there must be limitations to this strategy if intracellular integrity is meant to be kept stable. It has therefore been postulated that, apart from this cell-immanent mechanism, extracellular and intracellular electrolyte stores could assist in buffering osmotic imbalances.\n\nThe Edelman formula states that extracellular sodium is determined by the total amount of exchangeable body sodium (the major extracellular cation) plus potassium (the major intracellular cation) divided by total body water. Several studies have shown, that it only partially explains the changes in patients outside the osmotic equilibrium.\n\nTo better understand these physiological responses might not only promote the researcher's insight into the most basic cellular self-defense systems by measuring and comparing extra- and intracellular electrolyte concentrations with estimated changes in a patient that will be intravenously challenged with either water or sodium chloride 3%.\n\nThe evolution over time of extra- and intracellular sodium and other electrolytes will be assessed quantitatively in patients with impaired renal function after water or sodium chloride (NaCl) administration.",[27],[31,88,89,90],"prospective trial","intracellular measurements","Water-Electrolyte Imbalance","2025-09-10",{"date":93,"type":40},"2025-09-17",{"date":95,"type":40},"2023-07-01",{"date":97,"type":21},"2026-05-31",{"name":99,"class":47},"University of Cologne",{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":22,"phases":110,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":48},"100579246","protein-supplementation-in-hyponatremia-due-to-the-syndrome-of-inappropriate-antidiuresis-100579246","NCT06821802","Protein Supplementation in Hyponatremia Due to the Syndrome of Inappropriate Antidiuresis","Effect of Protein Supplementation in Hospitalized Patients With Hyponatremia Due to the Syndrome of Inappropriate Antidiuresis - a Monocentric Randomized Open-label Pragmatic Active-controlled Trial - the TREASUREx Trial","TREASUREx","Inclusion Criteria:\n\n* Adult patients with confirmed SIAD during the hospital stay or at screening, defined by:\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* Clinical euvolemia (no signs of hypovolemia or hypervolemia)\n\nExclusion Criteria:\n\n* Lactose intolerance, milk protein allergy, soy allergy, nuts allergy, or hypersensitivity to components of the protein supplement.\n* Inborn metabolic disorders affecting carbohydrate, lipid, or protein metabolism.\n* Severe symptomatic hyponatremia requiring 3% NaCl or intensive care.\n* New (within the last five days) treatment with SGLT2 inhibitors, vaptans or oral urea\n* Uncontrolled severe hypothyroidism (untreated)\n* Uncontrolled adrenal insufficiency (morning cortisol \\\u003C150nmol\u002Fl)\n* eGFR \\\u003C45 mL\u002Fmin\u002F1.73 m² (KDIGO G3b-5) or end-stage renal disease (dialysis)\n* Severe hepatic impairment or advanced symptomatic liver disease defined as past or current hepatic encephalopathy, liver cirrhosis Child C, or decompensated (bleeding, jaundice, hepatorenal syndrome)\n* Pregnancy, breastfeeding, or plans to become pregnant during the study.\n* End-of-life care\n* Lack of capacity or other reasons preventing from giving informed consent or following study procedures (e.g., due to language problems, psychological disorders, dementia, etc.)\n* Treatment with thiazid diuretic (must be stopped at least 48 hours before inclusion)\n\nPost-randomization Exclusion Criteria:\n\n* Type 1 diabetes or uncontrolled type 2 diabetes (HbA1c \\>8.0%)",{"count":109,"type":21},70,[24],"The goal of this study is to assess the impact of protein supplementation on hyponatremia caused by the syndrome of inappropriate antidiuresis during hospitalization.",[27,113],"Syndrome of Inappropriate Antidiuresis",[115,116,33,34],"dysregulated arginine vasopressin (AVP) secretion","increased renal AVP sensitivity","2025-07-07",{"date":119,"type":40},"2025-07-10",{"date":121,"type":40},"2025-04-14",{"date":123,"type":21},"2027-04",{"name":46,"class":47},{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":22,"phases":135,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":148},"100517665","phase-3-systematic-use-of-ddavp-to-prevent-serum-sodium-overcorrection-in-severe-hyponatremia-100517665","NCT06020495","Systematic Use of DDAVP to Prevent Serum Sodium Overcorrection in Severe Hyponatremia","Systematic Use of DDAVP to Prevent Serum Sodium Overcorrection in Severe Hyponatremia: a Multicenter Open-label Randomized Controlled Trial","DASSOH","Inclusion Criteria:\n\n* Adults ( ≥18 years)\n* Current admission in ICU\n* Severe hyponatremia defined by SNa \\\u003C120 mmol\u002FL in the presence of neurological symptoms (seizures, stupor defined as Glasgow score \\\u003C 12, or signs of brain herniation) or by SNa \\\u003C115 mmol\u002FL\n* Normal or decreased extracellular fluid volume\n\nExclusion Criteria:\n\n* Obvious increase of extracellular fluid volume (cirrhosis with ascites, congestive heart failure, nephrotic syndrome);\n* Hyponatremia caused by hyperglycaemia (\\> 30 mmol\u002FL) or hypertriglyceridemia (10 g\u002FL) or hyperproteinaemia (120 g\u002FL)\n* Severe acute kidney injury (KDIGO 3)\n* Severe chronic kidney disease (eGFR \\\u003C20 ml\u002Fmin)\n* Coronary patients well stabilized with trinitrine-based medicines\n* Recent neurosurgery or traumatic brain injury\n* Previous DDAVP or hypertonic fluid administration for the current episode of severe hyponatremia\n* SNa increased by 5 mmol or more between admission at hospital and randomisation (H0)\n* Known contraindication to DDAVP\n\n  * Allergy\n  * Syndrome of inappropriate antidiuretic hormone secretion (SIADH)\n  * History of unstable angina and\u002For known or suspected heart failure.\n  * Willebrand disease type IIB\n* Severe previous neurologic disability (Glasgow Outcome Scale: GOS \\\u003C 3)\n* Diabetes insipidus receiving DDAVP treatment\n* Moribund state (patient likely to die within 24h)\n* Need for invasive mechanic ventilation\n* Enrolment to another interventional study (clinical trial on medicinal product, medical device and interventional research involving human participants not concerning health product)\n* Pregnancy or breastfeeding\n* Subject deprived of freedom, subject under a legal protective measure\n* No affiliation to any health insurance system\n* Refusal to participate to the study (patient or legal representative or family member or close relative if present)",{"count":134,"type":21},260,[136],"PHASE3","ICU patients with severe hyponatremia and a high risk of rapid SNa overcorrection.",[27],"2025-05-20",{"date":141,"type":40},"2025-05-23",{"date":143,"type":40},"2024-12-17",{"date":145,"type":21},"2026-11-30",{"name":147,"class":47},"Assistance Publique - Hôpitaux de Paris",12,{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":156,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":159,"phases":4,"briefSummary":160,"conditions":161,"keywords":162,"overallStatus":170,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":4},"100554420","saline-infusion-test-in-hyponatremia-100554420","NCT06498856","Saline Infusion Test in Hyponatremia","SITH","Inclusion Criteria:\n\n* Plasma sodium 120-130 mmol\u002FL\n* Effective osmolality (2 x plasma sodium + plasma glucose) \\\u003C 275 milliosmol\u002FL\n* Age \\> 18 years\n\nExclusion Criteria:\n\n* Intensive care unit (ICU) admission\n* Adequate sodium correction rate: \\> 4 mmol\u002FL last 24 hours\n* Primary polydipsia: urine osmolality \\\u003C 100 mOsm\u002FL\n* Hypertonic saline therapy\n* Adrenal insufficiency\n* Severe heart failure: ejection fraction \\\u003C 35 % or clinical suspicion of decompensated heart failure\n* Ascites grade 3 (marked abdominal distention and discomfort)\n* Chronic renal failure stage 4 or 5: estimated glomerular filtration rate \\\u003C 30\n* Failure to submit informed consent",true,{"count":158,"type":21},100,"OBSERVATIONAL","Observational study of biochemical volume biomarker levels in response to a standardized intravenous isotonic saline infusion in patients with hyponatremia.",[27],[163,164,165,166,167,168,169],"Arginine vasopressin","Copeptin","Antidiuretic hormone","Saline infusion test","Fluid- and volume regulation","Renin","Aldosterone","NOT_YET_RECRUITING","2024-07-05",{"date":173,"type":40},"2024-07-12",{"date":175,"type":21},"2024-07",{"date":177,"type":21},"2028-12",{"name":179,"class":47},"University Hospital, Akershus"]