[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100548590":3},{"organization":4,"outcomesModule":7,"designInfo":54,"detailedDescription":56,"studyPopulation":57,"armGroups":53,"interventions":58,"overallOfficials":63,"centralContacts":67,"locations":73,"responsibleParty":325,"collaborators":53,"id":327,"slug":53,"hasResults":328,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":53,"eligibilityCriteria":332,"healthyVolunteers":328,"sex":333,"minAge":334,"maxAge":53,"enrollmentInfo":335,"targetDuration":338,"studyType":339,"phases":53,"briefSummary":340,"conditions":341,"keywords":346,"overallStatus":184,"whyStopped":53,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":356},{"fullName":5,"class":6},"Hospital Universitario 12 de Octubre","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":53},[9],{"measure":10,"description":11,"timeFrame":12},"Characterise the clinical practice of vasopressin use in the context of shock in a multicentre observational study.","Describing the time sequence of vasopressin and\u002For noradrenaline use (what is initiated first) during shock","90 days",[14,18,21,24,27,30,33,37,40,44,47,50],{"measure":15,"description":16,"timeFrame":17},"Assess what prompted the decision to initiate AVP","Assess what prompted the decision to initiate AVP: type of shock (vasoplegic, hypovolemic,...), perfusion parameters (as lactate) or noradrenaline dose (microgram\u002Fkg\u002Fminute)","Up to 7 days",{"measure":19,"description":20,"timeFrame":17},"Define the impact of starting AVP on noradrenaline dose","Define the impact of starting AVP on noradrenaline dose (microgram\u002Fkg\u002Fminute)",{"measure":22,"description":23,"timeFrame":17},"Define the impact of starting AVP on lactate level","Define the impact of starting AVP on lactate level (mmol\u002FL)",{"measure":25,"description":26,"timeFrame":17},"Observe when AVP is discontinued and how","Describe number of participants what AVP is discontinued first and how (abruptly or progressively)",{"measure":28,"description":29,"timeFrame":17},"Estimate the range of doses of AVP used","Estimate the range of doses of AVP used and the maximum dose used in routine clinical practice.",{"measure":31,"description":32,"timeFrame":17},"Incidence of side effects","Describe the incidence of side effects, whether it is related to AVP dose and patients' comorbidities.",{"measure":34,"description":35,"timeFrame":36},"28-day all-cause mortality","Death on or before study day 28","28 days",{"measure":38,"description":39,"timeFrame":12},"90-day all-cause mortality","Death on or before study day 90",{"measure":41,"description":42,"timeFrame":43},"Incidence of new renal replacement therapy","New receipt of renal replacement therapy after onset of shock","From onset of shock until hospital discharge, an average of 2 weeks",{"measure":45,"description":46,"timeFrame":36},"Vasopressor-free days to day 28","Number of days between day 28 and the end of the last period of vasopressor therapy prior to day 28",{"measure":48,"description":49,"timeFrame":36},"Intensive care unit-free days to day 28","Number of days between day 28 and the end of the last period of intensive care unit admission prior to day 28.",{"measure":51,"description":52,"timeFrame":36},"Hospital-free days to day 28","Number of days between day 28 and the end of the last period of hospital admission prior to day 28",null,{"allocation":53,"interventionModel":53,"interventionModelDescription":53,"primaryPurpose":53,"observationalModel":6,"timePerspective":55,"maskingInfo":53},"PROSPECTIVE","The main objective is to characterise the routine clinical practice of vasopressin use in the context of shock in a multicentre observational study. By collecting clinical, analytical and echocardiographic data in a uniform manner, describing the time sequence of vasopressin and\u002For noradrenaline use; how long vasopressin is used; and which vasoconstrictor is more frequently withdrawn earlier: vasopressin or noradrenaline.\n\nThe secondary objectives are:\n\n* to assess what motivated the decision to initiate AVP: type of shock, perfusion parameters, noradrenaline dose;\n* to define the impact of initiating AVP on noradrenaline dose (whether the dose can be reduced or not), on cardiac function (whether echocardiographic data improve or worsen) and on perfusion data (whether laboratory and clinical data such as lactate, capillary refill time, mottling score or diuresis improve or worsen);\n* estimate what is the dose range of AVP used and what is the maximum dose used in routine clinical practice;\n* observe when AVP is stopped, how (abruptly or progressively);\n* describe the incidence of side effects of AVP, whether it is related to the dose of AVP and the comorbidities of the patients;\n* assess medium\u002Flong-term outcomes: 28- and 90-day mortality, ICU and hospital stay, days of vasopressor support, days of mechanical ventilation, days of renal replacement.","Patients in shock receiving vasopressin",[59],{"type":60,"name":61,"description":62,"armGroupLabels":53,"otherNames":53},"DRUG","Vasopressin","Patients treated with vasopressin",[64],{"name":65,"affiliation":5,"role":66},"Raquel García Álvarez","PRINCIPAL_INVESTIGATOR",[68],{"name":69,"role":70,"phone":71,"phoneExt":53,"email":72},"Raquel García Álvarez, MD","CONTACT","+34913908243","raquelgarciaalvarez@gmail.com",[74,89,100,111,119,127,138,149,160,171,182,194,205,211,221,229,240,251,262,273,284,295,306,317],{"facility":75,"status":76,"city":77,"state":53,"zip":53,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":85,"contacts":86},"Hospital Universitario de A Coruña","NOT_YET_RECRUITING","A Coruña","Spain","ES",{"type":81,"coordinates":82},"Point",[83,84],-8.396,43.37135,{"lat":84,"lon":83},[87],{"name":88,"role":70,"phone":53,"phoneExt":53,"email":53},"Pablo Rama Maceiras",{"facility":90,"status":76,"city":91,"state":53,"zip":53,"country":78,"countryCode":79,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Hospital Universitario de Cruces","Barakaldo",{"type":81,"coordinates":93},[94,95],-2.98813,43.29639,{"lat":95,"lon":94},[98],{"name":99,"role":70,"phone":53,"phoneExt":53,"email":53},"Gontzal Tamayo",{"facility":101,"status":76,"city":102,"state":53,"zip":53,"country":78,"countryCode":79,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"Hospital de Sant Pau","Barcelona",{"type":81,"coordinates":104},[105,106],2.15899,41.38879,{"lat":106,"lon":105},[109],{"name":110,"role":70,"phone":53,"phoneExt":53,"email":53},"Marta Giné Servén",{"facility":112,"status":76,"city":102,"state":53,"zip":53,"country":78,"countryCode":79,"cosmosGeoPoint":113,"geoPoint":115,"contacts":116},"Hospital del Mar",{"type":81,"coordinates":114},[105,106],{"lat":106,"lon":105},[117],{"name":118,"role":70,"phone":53,"phoneExt":53,"email":53},"Ramón Adalia",{"facility":120,"status":76,"city":102,"state":53,"zip":53,"country":78,"countryCode":79,"cosmosGeoPoint":121,"geoPoint":123,"contacts":124},"Hospital Universitario Valle de Hebrón",{"type":81,"coordinates":122},[105,106],{"lat":106,"lon":105},[125],{"name":126,"role":70,"phone":53,"phoneExt":53,"email":53},"Miriam de Nadal",{"facility":128,"status":76,"city":129,"state":53,"zip":53,"country":78,"countryCode":79,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"Hospital Universitario de Basurto","Bilbao",{"type":81,"coordinates":131},[132,133],-2.92528,43.26271,{"lat":133,"lon":132},[136],{"name":137,"role":70,"phone":53,"phoneExt":53,"email":53},"Felipe Ortega Palacios",{"facility":139,"status":76,"city":140,"state":53,"zip":53,"country":78,"countryCode":79,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Hospital de Donostia","Donostia \u002F San Sebastian",{"type":81,"coordinates":142},[143,144],-1.97499,43.31283,{"lat":144,"lon":143},[147],{"name":148,"role":70,"phone":53,"phoneExt":53,"email":53},"Cristina García Fernández",{"facility":150,"status":76,"city":151,"state":53,"zip":53,"country":78,"countryCode":79,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"Hospital General Universitario de Elche","Elche",{"type":81,"coordinates":153},[154,155],-0.70107,38.26218,{"lat":155,"lon":154},[158],{"name":159,"role":70,"phone":53,"phoneExt":53,"email":53},"Ana Pérez Carbonell",{"facility":161,"status":76,"city":162,"state":53,"zip":53,"country":78,"countryCode":79,"cosmosGeoPoint":163,"geoPoint":167,"contacts":168},"Hospital Universitario de Cabueñes","Gijón",{"type":81,"coordinates":164},[165,166],-5.66152,43.53573,{"lat":166,"lon":165},[169],{"name":170,"role":70,"phone":53,"phoneExt":53,"email":53},"Pablo Fernández Solano",{"facility":172,"status":76,"city":173,"state":53,"zip":53,"country":78,"countryCode":79,"cosmosGeoPoint":174,"geoPoint":178,"contacts":179},"Complejo Asistencial Universitario de León","León",{"type":81,"coordinates":175},[176,177],-5.57032,42.60003,{"lat":177,"lon":176},[180],{"name":181,"role":70,"phone":53,"phoneExt":53,"email":53},"Rafael González de Castro",{"facility":183,"status":184,"city":185,"state":53,"zip":53,"country":78,"countryCode":79,"cosmosGeoPoint":186,"geoPoint":190,"contacts":191},"Hospital Lucus Augustus","RECRUITING","Lugo",{"type":81,"coordinates":187},[188,189],-7.55602,43.00992,{"lat":189,"lon":188},[192],{"name":193,"role":70,"phone":53,"phoneExt":53,"email":53},"Lorena Mouritz",{"facility":195,"status":76,"city":196,"state":53,"zip":53,"country":78,"countryCode":79,"cosmosGeoPoint":197,"geoPoint":201,"contacts":202},"Hospital General Universitario Gregorio Marañón","Madrid",{"type":81,"coordinates":198},[199,200],-3.70256,40.4165,{"lat":200,"lon":199},[203],{"name":204,"role":70,"phone":53,"phoneExt":53,"email":53},"Carlos Alberto Calvo García",{"facility":5,"status":184,"city":196,"state":53,"zip":53,"country":78,"countryCode":79,"cosmosGeoPoint":206,"geoPoint":208,"contacts":209},{"type":81,"coordinates":207},[199,200],{"lat":200,"lon":199},[210],{"name":65,"role":70,"phone":53,"phoneExt":53,"email":72},{"facility":212,"status":76,"city":196,"state":53,"zip":53,"country":78,"countryCode":79,"cosmosGeoPoint":213,"geoPoint":215,"contacts":216},"Hospital Universitario La Princesa",{"type":81,"coordinates":214},[199,200],{"lat":200,"lon":199},[217,219],{"name":218,"role":70,"phone":53,"phoneExt":53,"email":53},"Fernando Ramasco Rueda",{"name":220,"role":70,"phone":53,"phoneExt":53,"email":53},"Jesús Nieves Alonso",{"facility":222,"status":76,"city":196,"state":53,"zip":53,"country":78,"countryCode":79,"cosmosGeoPoint":223,"geoPoint":225,"contacts":226},"Hospital Universitario Ramón y Cajal",{"type":81,"coordinates":224},[199,200],{"lat":200,"lon":199},[227],{"name":228,"role":70,"phone":53,"phoneExt":53,"email":53},"Amal Azzam",{"facility":230,"status":76,"city":231,"state":53,"zip":53,"country":78,"countryCode":79,"cosmosGeoPoint":232,"geoPoint":236,"contacts":237},"Hospital Universitario Puerta de Hierro Majadahonda","Majadahonda",{"type":81,"coordinates":233},[234,235],-3.87182,40.47353,{"lat":235,"lon":234},[238],{"name":239,"role":70,"phone":53,"phoneExt":53,"email":53},"Reyes Iranzo",{"facility":241,"status":76,"city":242,"state":53,"zip":53,"country":78,"countryCode":79,"cosmosGeoPoint":243,"geoPoint":247,"contacts":248},"Complexo Hospitalario Universitario de Ourense","Ourense",{"type":81,"coordinates":244},[245,246],-7.86407,42.33669,{"lat":246,"lon":245},[249],{"name":250,"role":70,"phone":53,"phoneExt":53,"email":53},"Concepción Alonso",{"facility":252,"status":76,"city":253,"state":53,"zip":53,"country":78,"countryCode":79,"cosmosGeoPoint":254,"geoPoint":258,"contacts":259},"Hospital Universitario Central de Asturias","Oviedo",{"type":81,"coordinates":255},[256,257],-5.84476,43.36029,{"lat":257,"lon":256},[260],{"name":261,"role":70,"phone":53,"phoneExt":53,"email":53},"Beatriz Mancha Getino",{"facility":263,"status":76,"city":264,"state":53,"zip":53,"country":78,"countryCode":79,"cosmosGeoPoint":265,"geoPoint":269,"contacts":270},"Hospital Universitario Nuestra Señora de Candelaria","Santa Cruz de Tenerife",{"type":81,"coordinates":266},[267,268],-16.25462,28.46824,{"lat":268,"lon":267},[271],{"name":272,"role":70,"phone":53,"phoneExt":53,"email":53},"David Domínguez",{"facility":274,"status":76,"city":275,"state":53,"zip":53,"country":78,"countryCode":79,"cosmosGeoPoint":276,"geoPoint":280,"contacts":281},"Hospital Universitario Marqués de Valdecilla","Santander",{"type":81,"coordinates":277},[278,279],-3.80493,43.46589,{"lat":279,"lon":278},[282],{"name":283,"role":70,"phone":53,"phoneExt":53,"email":53},"Adriana Ixquic Reyes Echeverria",{"facility":285,"status":76,"city":286,"state":53,"zip":53,"country":78,"countryCode":79,"cosmosGeoPoint":287,"geoPoint":291,"contacts":292},"Hospital Clínico Universitario de Santiago","Santiago de Compostela",{"type":81,"coordinates":288},[289,290],-8.54569,42.88052,{"lat":290,"lon":289},[293],{"name":294,"role":70,"phone":53,"phoneExt":53,"email":53},"Manuel Taboada",{"facility":296,"status":76,"city":297,"state":53,"zip":53,"country":78,"countryCode":79,"cosmosGeoPoint":298,"geoPoint":302,"contacts":303},"Hospital Universitario Joan XXIII","Tarragona",{"type":81,"coordinates":299},[300,301],1.24544,41.11905,{"lat":301,"lon":300},[304],{"name":305,"role":70,"phone":53,"phoneExt":53,"email":53},"Diego Prendes Fernández",{"facility":307,"status":76,"city":308,"state":53,"zip":53,"country":78,"countryCode":79,"cosmosGeoPoint":309,"geoPoint":313,"contacts":314},"Hospital Clínico Universitario de Valencia","Valencia",{"type":81,"coordinates":310},[311,312],-0.37966,39.47391,{"lat":312,"lon":311},[315],{"name":316,"role":70,"phone":53,"phoneExt":53,"email":53},"Gerardo Aguilar",{"facility":318,"status":76,"city":308,"state":53,"zip":53,"country":78,"countryCode":79,"cosmosGeoPoint":319,"geoPoint":321,"contacts":322},"Hospital Universitari i Politècnic La Fe",{"type":81,"coordinates":320},[311,312],{"lat":312,"lon":311},[323],{"name":324,"role":70,"phone":53,"phoneExt":53,"email":53},"Miguel Ángel Rodenas",{"type":326,"investigatorFullName":53,"investigatorTitle":53,"investigatorAffiliation":53,"oldNameTitle":53,"oldOrganization":53},"SPONSOR","100548590",false,"NCT06422975","Registry of Patients in Shock Treated With Vasopressin","Prospective Multicentre Observational Study of Patients Treated With Vasopressin in Critical Care Units","Inclusion Criteria:\n\n* Any patient over 18 years of age who is in shock and requires the administration of vasoconstrictors, to whom vasopressin is administered in the operating theatre and\u002For critical care unit, according to best clinical practice.\n\nExclusion Criteria:\n\n* Non-consent by patient\u002Flegal representatives","ALL","18 Years",{"count":336,"type":337},500,"ESTIMATED","90 Days","OBSERVATIONAL","Arginine-vasopressin (AVP) is a non-catecholaminergic hormone produced in the hypothalamus and released into the circulation via the neurohypophysis. It has different actions depending on the receptors through which it acts: V1 (vasoconstriction, platelet aggregation, efferent arteriole constriction of the renal glomerulus, glycogenolysis); V2 (water reabsorption, release of von Willebrand factor and factor VIII); V3 (increased cortisol and insulin).\n\nSeptic shock is the most common cause of vasoplegic shock and its management includes control of the focus, early antibiotic therapy, volume resuscitation, vasopressor therapy, support of various organ dysfunctions, as well as monitoring and follow-up.\n\nThe Surviving Sepsis Campaign (a global initiative to improve sepsis management) recommends noradrenaline as the first line of vasopressor therapy and early addition of AVP as a second line rather than further up-titration of noradrenaline when signs of hypoperfusion persist, through its action primarily on V1.\n\nThe rationale for its use in septic shock would be:\n\n* endogenous vasopressin deficiency present in septic shock;\n* as a catecholamine-sparing strategy, reducing the side effects of catecholamines;\n* its potential nephroprotective effect;\n* its use should be early.\n\nThe uncertainties surrounding the use of AVP in septic shock and other types of shock are many, hence the need for this registry.",[342,343,344,345],"Vasopressin Causing Adverse Effects in Therapeutic Use","Shock","Vasopressor Adverse Reaction","Vasopressin Deficiency",[61,343],"2024-07-11",{"date":349,"type":350},"2024-07-15","ACTUAL",{"date":352,"type":350},"2024-07-09",{"date":354,"type":337},"2026-06",{"name":5,"class":6},24]