[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100492483":3},{"organization":4,"outcomesModule":7,"designInfo":54,"detailedDescription":57,"studyPopulation":58,"armGroups":59,"interventions":65,"overallOfficials":69,"centralContacts":74,"locations":83,"responsibleParty":104,"collaborators":53,"id":107,"slug":53,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":108,"sex":114,"minAge":115,"maxAge":53,"enrollmentInfo":116,"targetDuration":53,"studyType":119,"phases":53,"briefSummary":120,"conditions":121,"keywords":123,"overallStatus":85,"whyStopped":53,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"University of Cologne","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":22,"otherOutcomes":53},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"Changes in Plasma Sodium","Measurement of plasma sodium in blood samples","baseline, every day up to 30 days",{"measure":14,"description":15,"timeFrame":12},"Changes in plasma osmolality","Measurement of plasma osmolality for determination of electrolyte-free water clearance before, during and after hyponatremia treatment",{"measure":17,"description":18,"timeFrame":12},"Changes in urine osmolality","Determination of electrolyte-free water clearance before, during and after hyponatremia treatment by measurement of urine osmolality",{"measure":20,"description":21,"timeFrame":12},"Changes in urine volume","Determination of electrolyte-free water clearance before, during and after hyponatremia treatment by measurement of urine volume",[23,26,29,32,35,38,41,44,47,50],{"measure":24,"description":25,"timeFrame":12},"Changes in body weight","Measurement of body weight before, during and after hyponatremia treatment by bioimpedance measurement",{"measure":27,"description":28,"timeFrame":12},"Changes in total body water","Measurement of body water before, during and after hyponatremia treatment by bioimpedance measurement",{"measure":30,"description":31,"timeFrame":12},"Changes in intracellular volume","Measurement of intracellular volume before, during and after hyponatremia treatment by bioimpedance measurement",{"measure":33,"description":34,"timeFrame":12},"Changes in extracellular volume","Measurement of extracellular volume before, during and after hyponatremia treatment by bioimpedance measurement",{"measure":36,"description":37,"timeFrame":12},"Changes in blood pressure","Measurement of blood pressure before, during and after hyponatremia treatment",{"measure":39,"description":40,"timeFrame":12},"Changes in cell size","Determination of blood cell size via measurement of mean corpuscular volume",{"measure":42,"description":43,"timeFrame":12},"Changes in intracellular electrolyte levels","Measurement of whole blood samples via ICP-mass spectrometry",{"measure":45,"description":46,"timeFrame":12},"Changes in copeptin levels","Measurement of copeptin in blood samples",{"measure":48,"description":49,"timeFrame":12},"Changes in renin levels","Measurement of renin in blood samples",{"measure":51,"description":52,"timeFrame":12},"Changes in aldosterone levels","Measurement of aldosterone in blood samples",null,{"allocation":53,"interventionModel":53,"interventionModelDescription":53,"primaryPurpose":53,"observationalModel":55,"timePerspective":56,"maskingInfo":53},"COHORT","PROSPECTIVE","Achieving recommended treatment targets in management of hyponatremia is challenging: plasma sodium must be increased effectively but, at the same time, overcorrection has to be prevented. Yet, predictors of change of sodium over time have not been delineated properly. It was found, that evidence hinting to the fact that sodium baseline itself is crucial with respect to sodium evolution.\n\nThe goal of this study is to gather prospective data in order to precisely delineate the role of initial sodium levels by correlating those to plasma sodium evolution and electrolyte free water evolution. It is aimed to decipher patterns of sodium evolution with respect to anthropometric data, such as body composition analyses and blood pressure and markers of innate regulation mechanisms of body volume like aldosterone and renin. In addition, apart from these clinical aspects, a better appreciation of the physiological responses to hyponatremia treatment in terms of water and electrolyte balances is undoubtedly necessary to improve understanding of the body's mechanisms involved in osmotic homeostasis and cell volume control. Since studies to date also lack consideration of the intracellular department, the aim is to close that gap.","Patients with non-hypervolemic hyponatremia",[60],{"label":61,"type":53,"description":62,"interventionNames":63},"Patients","Patients with non-hypervolemic hypotonic hyponatremia",[64],"Other: Patients",[66],{"type":6,"name":61,"description":67,"armGroupLabels":68,"otherNames":53},"Patients will get study-specific measurements within first 5 days of standard of care treatment of hyponatremia or until discharge",[61],[70],{"name":71,"affiliation":72,"role":73},"Volker Burst, MD, Prof.","University Hospital of Cologne","PRINCIPAL_INVESTIGATOR",[75,80],{"name":76,"role":77,"phone":78,"phoneExt":53,"email":79},"Volker Burst, MD, Prof","CONTACT","+49 221-478-97222","volker.burst@uk-koeln.de",{"name":81,"role":77,"phone":53,"phoneExt":53,"email":82},"Sadrija Cukoski","sadrija.cukoski@uk-koeln.de",[84],{"facility":72,"status":85,"city":86,"state":53,"zip":87,"country":88,"countryCode":89,"cosmosGeoPoint":90,"geoPoint":95,"contacts":96},"RECRUITING","Cologne","50937","Germany","DE",{"type":91,"coordinates":92},"Point",[93,94],6.95,50.93333,{"lat":94,"lon":93},[97,100,101,102],{"name":98,"role":77,"phone":99,"phoneExt":53,"email":79},"Volker Burst, MD","+49(0)221 478 97222",{"name":81,"role":77,"phone":53,"phoneExt":53,"email":82},{"name":71,"role":73,"phone":53,"phoneExt":53,"email":53},{"name":81,"role":103,"phone":53,"phoneExt":53,"email":53},"SUB_INVESTIGATOR",{"type":73,"investigatorFullName":105,"investigatorTitle":106,"investigatorAffiliation":5,"oldNameTitle":53,"oldOrganization":53},"Volker Burst","Prof. Dr.","100492483",false,"NCT05692726","Evaluation of Volume and Electrolyte Balance in Hyponatremia Treatment - a Prospective Observational Trial","Evaluation of Volume and Electrolyte Balance in Hyponatremia Treatment - a Prospective Observational Trial (EvenT)","EvenT","Inclusion Criteria:\n\n* Adult patients ≥ 18 years\n* Hypotonic hyponatremia\n\n  * glucose-corrected plasma sodium \\\u003C130 mmol\u002Fl\n  * serum osmolality \\\u003C280 mosmol\u002Fkg or lack of signs of non-hypotonic hyponatremia\n\nExclusion Criteria:\n\n* Signs of extracellular volume expansion\n* Patients with liver cirrhosis and severe liver damage AST\u002FALT\\>3xULN, AP\\>6xULN, Bilirubin ≥ 3mg\u002Fdl\n* Patients with heart failure\n* Patients on dialysis and\u002For patients with oliguric renal impairment and plasma creatinine ≥ 3mg\u002Fdl\n* Patients after organ transplantation","ALL","18 Years",{"count":117,"type":118},50,"ESTIMATED","OBSERVATIONAL","To assess quantitatively the evolution over time of electrolyte-free water clearance and electrolyte mass balance in patients with non-hypervolemic hypotonic hyponatremia",[122],"Non-hypervolemic Hyponatremia",[124,125],"Electrolyte-free water clearance","hyponatremia","2025-09-10",{"date":128,"type":129},"2025-09-11","ACTUAL",{"date":131,"type":129},"2022-10-15",{"date":133,"type":118},"2026-09-30",{"name":5,"class":6},1]