[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562577":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":37,"centralContacts":42,"locations":51,"responsibleParty":204,"collaborators":23,"id":206,"slug":207,"hasResults":208,"nctId":209,"briefTitle":210,"officialTitle":210,"acronym":211,"eligibilityCriteria":212,"healthyVolunteers":208,"sex":213,"minAge":214,"maxAge":215,"enrollmentInfo":216,"targetDuration":23,"studyType":219,"phases":220,"briefSummary":222,"conditions":223,"keywords":23,"overallStatus":227,"whyStopped":23,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":237},{"fullName":5,"class":6},"Assistance Publique Hopitaux De Marseille","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"NDI-PP- CDI groups","EXPERIMENTAL","Copeptin represents a new biomarker, direct mirror of AVP release with remarkable characteristics (stable, rapid determination, small blood volume). Copeptin has become a diagnostic tool in adult PPS and eliminated WDT in the diagnostic process. In children, basal copeptin values help for NDI and to exclude CDI (basal copeptin threshold \\> 30 and \\>3.53 pmol\u002Fl (Se 100%, Sp 87.4%), respectively). Below 3.53 pmol\u002Fl, basal copeptin performance was inadequate to discriminate PP and CDI, highlighting the relevance of the stimulated copeptin study to improve this strategy.",[13,14,15,16],"Procedure: Measure of Basal Copeptin level","Procedure: Measure of arginine-stimulated copeptin","Procedure: IRM","Behavioral: Water reduction at home",[18,24,28,32],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"PROCEDURE","Measure of Basal Copeptin level","Copeptin test is performed after solid fasting since midnight without water restriction. After blood collection on heparin tube used for biological inclusion criteria, heparinized plasma is transferred to Timone University hospital (transport temperature +4°C) for screening copeptin assay.\n\nThe basal copeptin level determines the next step:\n\n1. copeptin ≥ 30 pmol\u002FL defines the diagnosis of NDI and results in a specific care;\n2. copeptin \\< 30 pmol\u002FL defines the group of eligible patients for arginine stimulation",[9],null,{"type":19,"name":25,"description":26,"armGroupLabels":27,"otherNames":23},"Measure of arginine-stimulated copeptin","The arginine-stimulated copeptin test start at 8 am, after solid fasting since midnight without water restriction, and 30 min of rest in decubitus position. A dose of 0.5 g\u002Fkg of arginine (maximum 40g) diluted in 0.9% NaCl is infused over 30 min through a peripheral venous line. Copeptin is measured at T0 (before infusion), T45, T60, T90, and T120 min after infusion.",[9],{"type":19,"name":29,"description":30,"armGroupLabels":31,"otherNames":23},"IRM","Based on our previous study, patients with basal copeptin value over 3.53 pmol\u002FL are considered as positive diagnosis of PP (Se 100%, Sp 87.4%) and cerebral MRI is not performed for this group of patients (PP group).\n\nA cerebral and pituitary MRI performed according to reference procedures (without and with contrast medium used in routine care) for patients considered as an uncertain diagnosis (UD) based on basal copeptin value (\\< 3.53 pmol\u002FL). MRI interpretation is performed by two independent neuroradiologists (one from the recruiting center and one from the pilot center). In case of discrepancies, a third independent interpretation will be performed by a neuroradiologist from the coordinating center. Abnormal pituitary MRI (thickened pituitary stalk pituitary tumor, ectopic neurohypophysis, septo-optic dysplasia, empty sellar, Rathke pouch) allows a diagnosis of CDI leading to etiological investigations and AVP treatment.",[9],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":23},"BEHAVIORAL","Water reduction at home","Patients with basal copeptin ≥ 3.53 pmol\u002Fl (PP group), and UD patients with normal MRI have gradual reduction of water intake at home without AVP treatment : gradual reduction with 20% in the first week, 30% in the second, 40% in the third, reaching 50% of daily fluid in the last week including restriction overnight, deletion drink before sleep. Some recommendations will be provided to help physicians. For all these latest patients, a clinical reassessment (weight, height, heart rate, blood pressure, input\u002Foutput 24 hours balance) is performed one month later.",[9],[38],{"name":39,"affiliation":40,"role":41},"Rachel REYNAUD, Pr","AP-HM","PRINCIPAL_INVESTIGATOR",[43,48],{"name":44,"role":45,"phone":46,"phoneExt":23,"email":47},"Rachel REYNAUD","CONTACT","0491388040","Rachel.REYNAUD@ap-hm.fr",{"name":49,"role":45,"phone":23,"phoneExt":23,"email":50},"Rawand MASOUD","rawand.masoud@ap-hm.fr",[52,66,77,88,99,111,122,130,138,149,160,171,182,193],{"facility":53,"status":23,"city":54,"state":23,"zip":23,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"CHU Angers","Angers","France","FR",{"type":58,"coordinates":59},"Point",[60,61],-0.55202,47.47156,{"lat":61,"lon":60},[64],{"name":65,"role":41,"phone":23,"phoneExt":23,"email":23},"Régis COUTANT",{"facility":67,"status":23,"city":68,"state":23,"zip":23,"country":55,"countryCode":56,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"CHU de Bordeaux","Bordeaux",{"type":58,"coordinates":70},[71,72],-0.58046,44.84124,{"lat":72,"lon":71},[75],{"name":76,"role":41,"phone":23,"phoneExt":23,"email":23},"Pascal BARAT",{"facility":78,"status":23,"city":79,"state":23,"zip":23,"country":55,"countryCode":56,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"CHU Lille","Lille",{"type":58,"coordinates":81},[82,83],3.05512,50.63391,{"lat":83,"lon":82},[86],{"name":87,"role":41,"phone":23,"phoneExt":23,"email":23},"Iva GUEORGUIEVA",{"facility":89,"status":23,"city":90,"state":23,"zip":23,"country":55,"countryCode":56,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"HCL","Lyon",{"type":58,"coordinates":92},[93,94],4.84789,45.74906,{"lat":94,"lon":93},[97],{"name":98,"role":41,"phone":23,"phoneExt":23,"email":23},"Carine VILLANUEVA",{"facility":100,"status":23,"city":101,"state":23,"zip":23,"country":55,"countryCode":56,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Assistance Publique Hopitaux de Marseille","Marseille",{"type":58,"coordinates":103},[104,105],5.38107,43.29695,{"lat":105,"lon":104},[108,109],{"name":44,"role":45,"phone":46,"phoneExt":23,"email":47},{"name":110,"role":45,"phone":23,"phoneExt":23,"email":50},"Rawand Masoud",{"facility":112,"status":23,"city":113,"state":23,"zip":23,"country":55,"countryCode":56,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"CHU Montpellier","Montpellier",{"type":58,"coordinates":115},[116,117],3.87635,43.61093,{"lat":117,"lon":116},[120],{"name":121,"role":41,"phone":23,"phoneExt":23,"email":23},"Cyril AMOUROUX",{"facility":123,"status":23,"city":124,"state":23,"zip":23,"country":55,"countryCode":56,"cosmosGeoPoint":125,"geoPoint":129,"contacts":23},"CHU Nantes","Nantes",{"type":58,"coordinates":126},[127,128],-1.55336,47.21725,{"lat":128,"lon":127},{"facility":131,"status":23,"city":132,"state":23,"zip":23,"country":55,"countryCode":56,"cosmosGeoPoint":133,"geoPoint":137,"contacts":23},"CHU Nice","Nice",{"type":58,"coordinates":134},[135,136],7.26608,43.70313,{"lat":136,"lon":135},{"facility":139,"status":23,"city":140,"state":23,"zip":23,"country":55,"countryCode":56,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"AP-HP","Paris",{"type":58,"coordinates":142},[143,144],2.3488,48.85341,{"lat":144,"lon":143},[147],{"name":148,"role":41,"phone":23,"phoneExt":23,"email":23},"Agnes LINGLART",{"facility":150,"status":23,"city":151,"state":23,"zip":23,"country":55,"countryCode":56,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"CH Pau","Pau",{"type":58,"coordinates":153},[154,155],-0.35583,43.31117,{"lat":155,"lon":154},[158],{"name":159,"role":41,"phone":23,"phoneExt":23,"email":23},"Laure OILLEAU",{"facility":161,"status":23,"city":162,"state":23,"zip":23,"country":55,"countryCode":56,"cosmosGeoPoint":163,"geoPoint":167,"contacts":168},"CHU Reims","Reims",{"type":58,"coordinates":164},[165,166],4.02853,49.26526,{"lat":166,"lon":165},[169],{"name":170,"role":41,"phone":23,"phoneExt":23,"email":23},"Pierre-François SOUCHON",{"facility":172,"status":23,"city":173,"state":23,"zip":23,"country":55,"countryCode":56,"cosmosGeoPoint":174,"geoPoint":178,"contacts":179},"CHU Rennes","Rennes",{"type":58,"coordinates":175},[176,177],-1.67431,48.11109,{"lat":177,"lon":176},[180],{"name":181,"role":41,"phone":23,"phoneExt":23,"email":23},"SAADE Marie Béatrice",{"facility":183,"status":23,"city":184,"state":23,"zip":23,"country":55,"countryCode":56,"cosmosGeoPoint":185,"geoPoint":189,"contacts":190},"CHU Rouen","Rouen",{"type":58,"coordinates":186},[187,188],1.09932,49.44313,{"lat":188,"lon":187},[191],{"name":192,"role":41,"phone":23,"phoneExt":23,"email":23},"Mireille CASTANET",{"facility":194,"status":23,"city":195,"state":23,"zip":23,"country":55,"countryCode":56,"cosmosGeoPoint":196,"geoPoint":200,"contacts":201},"CHU Toulouse","Toulouse",{"type":58,"coordinates":197},[198,199],1.44367,43.60426,{"lat":199,"lon":198},[202],{"name":203,"role":41,"phone":23,"phoneExt":23,"email":23},"Thomas EDOUARD",{"type":205,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100562577","arginin-stimulated-copeptin-in-polyuria-polydipsia-syndrome-in-children-100562577",false,"NCT06604975","Arginin-stimulated Copeptin in Polyuria-polydipsia Syndrome in Children","COPEPCHILD","Inclusion Criteria:\n\n* Children aged 2 to 18 years with polyuro-polydipsia syndrome (defined as hypotonic diuresis \\> 50 mL\u002Fkg\u002Fday in pediatric age or 30 mL\u002Fkg\u002Fday in late puberty (Tanner 5)) presenting for differential diagnosis between PP and DIC\n* Basal copeptin of less than 30 pmol\u002Fl\n* Agreeing to participate in the study\n* Whose two parents' consent to have their child participate in the study.\n\nExclusion Criteria:\n\n* Diabetes mellitus\n* Unbalanced dysthyroidism\n* Corticotropic deficiency\n* Ionic disorders (dysnatremia \\< 135 or \\> 145 mmol\u002Fl, dyskalemia \\< 3 or \\> 5 mmol\u002Fl, corrected dyscalcemia \\< 2.2 or \\> 2.6 mmol\u002FL)\n* Moderate to severe clinical dehydration (recent weight loss \\> 5% of body weight, clinical or biological signs of dehydration) requiring immediate therapeutic management\n* Renal failure with GFR \\< 60 mL\u002Fmin\u002F1.73 m2\n* Uropathy\n* Tumor syndrome (except hypothalamo-pituitary tumor)\n* Intracranial hypertension\n* ROHHAD syndrome\n* Fever or biological inflammatory syndrome with CRP \\> 5 mg\u002FL\n* Hepatic insufficiency\n* Contraindication to MRI\n* Contraindication to progressive water intake restrictions\n* History of contraindication to arginine\n* Positive test for Pregnancy\n* Lack of authorization by both parents or legal representatives","ALL","2 Years","18 Years",{"count":217,"type":218},155,"ESTIMATED","INTERVENTIONAL",[221],"NA","The exploration of polyuro-polydipsia syndrome (PPS) with hypotonic polyuria should distinguished, primary polydipsia (PP) due to excessive water intake, central diabetes insipidus (CDI) related to insufficient secretion of antidiuretic hormone (AVP), and nephrogenic diabetes insipidus (NDI) related to AVP insensitivity. The determination of plasma AVP is not relevant (unstable concentration, short in vitro half-life, long technical time and large blood sample). The differential diagnosis is currently based on a water deprivation test (WDT), an indirect reflection of AVP action, requiring more than 6 hours of hospitalization with risk of dehydration and low accuracy. Copeptin represents a new biomarker, direct mirror of AVP release with remarkable characteristics (stable, rapid determination, small blood volume). Copeptin has become a diagnostic tool in adult PPS and eliminated WDT in the diagnostic process. In children, basal copeptin values help for NDI and to exclude CDI (basal copeptin threshold \\> 30 and \\> 3.53 pmol\u002Fl (Se 100%, Sp 87.4%), respectively). Below 3.53 pmol\u002Fl, basal copeptin performance was inadequate to discriminate PP and CDI, highlighting the relevance of the stimulated copeptin study to improve this strategy. The arginine stimulation test is widely used as a simple, short duration (2 hours) and well tolerated tool to diagnose growth hormone deficiency in pediatrics. The performance of this test for copeptin stimulation was studied in adults with PPS with a high diagnostic accuracy.\n\nThe aim of the study is identify the best discriminant threshold of the arginine stimulation test in the uncertain diagnosis (basal copeptin \\\u003C30 pmol\u002Fl) in the polyuro-polydipsic syndrome in children.\n\nThen evaluate the discriminative capacities of the arginine stimulation test between the primary polydipsia and central insipid diabetes in the polyuro-polydipsic syndrome in children. And finally evaluate the cost-effectiveness of a new decisional algorithm for the differential diagnosis of PPS in children and evaluate the impact of infusion volume on copeptin secretion using the protidemia copeptin ratio.",[224,225,226],"Primary Polydipsia","Central Diabetes Insipidus","Nephrogenic Diabetes Insipidus","NOT_YET_RECRUITING","2025-02-12",{"date":230,"type":231},"2025-02-13","ACTUAL",{"date":233,"type":218},"2025-03",{"date":235,"type":218},"2028-07",{"name":5,"class":6},14]