[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551778":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":45,"studyPopulation":38,"armGroups":46,"interventions":59,"overallOfficials":68,"centralContacts":77,"locations":86,"responsibleParty":176,"collaborators":178,"id":185,"slug":38,"hasResults":186,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":186,"sex":192,"minAge":193,"maxAge":38,"enrollmentInfo":194,"targetDuration":38,"studyType":197,"phases":198,"briefSummary":200,"conditions":201,"keywords":203,"overallStatus":89,"whyStopped":38,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":218},{"fullName":5,"class":6},"Hospital do Coracao","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":38},[9],{"measure":10,"description":11,"timeFrame":12},"All-cause mortality or renal replacement therapy","Composite of all-cause mortality or renal replacement therapy within 28 days after randomization.","28 days",[14,17,20,23,26,29,32,35],{"measure":15,"description":16,"timeFrame":12},"All-cause mortality","All-cause mortality within 28 days after randomization",{"measure":18,"description":19,"timeFrame":12},"Renal replacement-therapy","Need of renal replacement therapy within 28 days after randomization.",{"measure":21,"description":22,"timeFrame":12},"Renal replacement-free days","Renal-replacement free days are defined by the number of days a patient is alive and free of renal replacement support between randomization and day 28. Non-survivors will be considered to have zero renal replacement-free days.",{"measure":24,"description":25,"timeFrame":12},"ICU-free days","Number of days a patient is alive and outside the ICU between randomization and day 28. Non-survivors will be considered to have zero ICU-free days.",{"measure":27,"description":28,"timeFrame":12},"Hospital-free days","Number of days a patient is alive and outside the hospital between randomization and day 28. Non-survivors will be considered to have zero hospital-free days.",{"measure":30,"description":31,"timeFrame":12},"Organ support-free days and its components","The definition of organ support involves three components: renal replacement therapy, invasive mechanical ventilation, and vasopressor use.\n\nOrgan support-free days are defined by the number of days a patient is alive and free of all three organ support therapies between randomization and day 28. Non-survivors will be considered to have zero organ support-free days.",{"measure":33,"description":34,"timeFrame":12},"Cardiac arrhythmias","Occurrence of cardiac arrhythmias between randomization and day 28",{"measure":36,"description":37,"timeFrame":12},"Ischemic events","Occurrence of mesenteric ischemia, ischemic stroke, digital ischemia and acute coronary syndrome between randomization and day 28",null,{"allocation":40,"interventionModel":41,"interventionModelDescription":38,"primaryPurpose":42,"observationalModel":38,"timePerspective":38,"maskingInfo":43},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":44,"maskingDescription":38,"whoMasked":38},"NONE","Sepsis is defined as a life-threatening organ dysfunction caused by a dysregulated body response to infection. Its most severe form, septic shock, occurs when underlying circulatory and cellular metabolic abnormalities are pronounced, indicating greater severity and higher mortality. Vasopressor use is a cornerstone aspect in the treatment of critically ill patients with sepsis-associated hemodynamic dysfunction, with norepinephrine, a catecholamine, being the vasopressor of choice.\n\nVasopressin is an endogenous peptide hormone with potential advantages over norepinephrine in a catecholamine-sparing strategy for treating sepsis-associated hemodynamic dysfunction.\n\nThis is a phase 3, multicenter, open-label, randomized controlled trial. Adult patients with sepsis-associated hemodynamic dysfunction in the ICU may be eligible to participate. We aim to enroll 2,800 patients.",[47,53],{"label":48,"type":49,"description":50,"interventionNames":51},"Early Vasopressin","EXPERIMENTAL","After randomization, vasopressin will be initiated and titrated up to 0.04U\u002Fmin to maintain the target mean arterial pressure (MAP). Concurrently, norepinephrine will be reduced, with the goal of using the maximum dose of vasopressin and minimizing or eliminating the use of norepinephrine, while still maintaining the target MAP.",[52],"Drug: Early Vasopressin",{"label":54,"type":55,"description":56,"interventionNames":57},"Norepinephrine plus vasopressin for rescue","ACTIVE_COMPARATOR","After randomization, norepinephrine will be titrated to maintain the target MAP. Vasopressin will be introduced as a rescue strategy only if the norepinephrine dose exceeds 0.5 μg\u002Fkg\u002Fmin. Once vasopressin is initiated, it can be titrated up to 0.04U\u002Fmin to help maintain the target MAP if the norepinephrine dose remains above 0.5 μg\u002Fkg\u002Fmin.",[58],"Drug: Norepinephrine and Vasopressin for Rescue",[60,64],{"type":61,"name":48,"description":62,"armGroupLabels":63,"otherNames":38},"DRUG","Early Vasopressin group: Vasopressin up to 0.04U\u002Fmin initiated after randomization.",[48],{"type":61,"name":65,"description":66,"armGroupLabels":67,"otherNames":38},"Norepinephrine and Vasopressin for Rescue","Norepinephrine and Vasopressin for Rescue group: Vasopressin up to 0.04U\u002Fmin initiated only if norepinephrine dose exceeds 0.5 μg\u002Fkg\u002Fmin.",[54],[69,73],{"name":70,"affiliation":71,"role":72},"Bruno M Tomazini, MD","Hcor Research Institute","PRINCIPAL_INVESTIGATOR",{"name":74,"affiliation":75,"role":76},"Machado R Flavia, PhD","Universidade Federal de São Paulo","STUDY_CHAIR",[78,82],{"name":70,"role":79,"phone":80,"phoneExt":38,"email":81},"CONTACT","+5511982839173","btomazini@hcor.com.br",{"name":83,"role":79,"phone":84,"phoneExt":38,"email":85},"Alexandre Biasi Cavalcanti, PhD","+551130536611","abiasi@hcor.com.br",[87,103,116,129,140,150,159,167],{"facility":88,"status":89,"city":90,"state":91,"zip":38,"country":92,"countryCode":93,"cosmosGeoPoint":94,"geoPoint":99,"contacts":100},"Hospital Geral de Caxias do Sul","RECRUITING","Caxias do Sul","Rio Grande do Sul","Brazil","BR",{"type":95,"coordinates":96},"Point",[97,98],-51.17944,-29.16806,{"lat":98,"lon":97},[101],{"name":102,"role":79,"phone":38,"phoneExt":38,"email":38},"Emerson Silva",{"facility":104,"status":89,"city":105,"state":106,"zip":38,"country":92,"countryCode":93,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Hospital Nereu Ramos","Florianópolis","Santa Catarina",{"type":95,"coordinates":108},[109,110],-48.54917,-27.59667,{"lat":110,"lon":109},[113],{"name":114,"role":79,"phone":38,"phoneExt":38,"email":115},"Israel Maia, PhD","israels.maia@gmail.com ;",{"facility":117,"status":118,"city":119,"state":120,"zip":38,"country":92,"countryCode":93,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Hospital SEPACO","NOT_YET_RECRUITING","São Paulo","S",{"type":95,"coordinates":122},[123,124],-46.63611,-23.5475,{"lat":124,"lon":123},[127],{"name":128,"role":79,"phone":38,"phoneExt":38,"email":38},"Flávio Freitas",{"facility":130,"status":118,"city":131,"state":119,"zip":38,"country":92,"countryCode":93,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Hospital de Amor - Unidade Barretos (Fundação PIO XII)","Barretos",{"type":95,"coordinates":133},[134,135],-48.56778,-20.55722,{"lat":135,"lon":134},[138],{"name":139,"role":79,"phone":38,"phoneExt":38,"email":38},"Cristina Amendola",{"facility":5,"status":89,"city":119,"state":119,"zip":141,"country":92,"countryCode":93,"cosmosGeoPoint":142,"geoPoint":144,"contacts":145},"05435000",{"type":95,"coordinates":143},[123,124],{"lat":124,"lon":123},[146,148],{"name":147,"role":79,"phone":38,"phoneExt":38,"email":38},"Marcelo Romano, MD",{"name":149,"role":79,"phone":38,"phoneExt":38,"email":38},"Luzia Taniguchi, MSc",{"facility":151,"status":118,"city":119,"state":119,"zip":38,"country":92,"countryCode":93,"cosmosGeoPoint":152,"geoPoint":154,"contacts":155},"BP-A Beneficiência Portuguesa de São Paulo",{"type":95,"coordinates":153},[123,124],{"lat":124,"lon":123},[156],{"name":157,"role":79,"phone":38,"phoneExt":38,"email":158},"Viviane Veiga","dveiga@uol.com.br",{"facility":160,"status":118,"city":119,"state":119,"zip":38,"country":92,"countryCode":93,"cosmosGeoPoint":161,"geoPoint":163,"contacts":164},"Hospital Alemão Oswaldo Cruz",{"type":95,"coordinates":162},[123,124],{"lat":124,"lon":123},[165],{"name":166,"role":79,"phone":38,"phoneExt":38,"email":38},"Mino Cestari, MD",{"facility":168,"status":89,"city":119,"state":119,"zip":38,"country":92,"countryCode":93,"cosmosGeoPoint":169,"geoPoint":171,"contacts":172},"Hospital São Paulo - UNIFESP",{"type":95,"coordinates":170},[123,124],{"lat":124,"lon":123},[173],{"name":174,"role":79,"phone":38,"phoneExt":38,"email":175},"Flavia Machado","frmachado@unifesp.br;",{"type":177,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR",[179,182],{"name":180,"class":181},"Brazilian Research In Intensive Care Network","NETWORK",{"name":183,"class":184},"National Institute of Science and Technology (INCT) in Precision Intensive Care Medicine","UNKNOWN","100551778",false,"NCT06464510","Norepinephrine and Vasopressin for Rescue Versus Early Vasopressin for Vasopressor Dependent Sepsis","Norepinephrine and Vasopressin for Rescue Versus Early Vasopressin for Vasopressor Dependent Sepsis: An Open-label, Multicenter, Randomized, Controlled Trial: NoVa","NoVa","Inclusion Criteria:\n\n* Patients with vasopressor dependent sepsis, defined by infection suspicion and antibiotic administration or laboratory confirmed viral infection, plus hypotension with the need of vasopressors for at least one hour;\n* Admitted or expected to be admitted to the ICU in the next 12 hours\n* Adequate volume resuscitation in the opinion of the attending physician\n* Use of norepinephrine \\> 0.05μg\u002FKg\u002Fmin and ≤ 0.25μg\u002FKg\u002Fmin for at least 1 hour and at most 24 hours at the time of inclusion\n\nExclusion Criteria:\n\n* Use of norepinephrine \\> 0.25μg\u002FKg\u002Fmin in the last 24 hours, except when administered transiently in the context of sedation for a procedure or the initial phase of volume resuscitation for a period of less than one hour\n* Dialysis-dependent chronic kidney disease or acute kidney injury that received renal replacement therapy during current hospitalization or are expected to receive renal replacement therapy in the next 24 hours\n* Use of other vasopressors (except norepinephrine) at the moment of inclusion\n* Use of vasopressors for sepsis in the last 7 days\n* Suspected or confirmed acute mesenteric ischemia\n* Anaphylaxis or known hypersensitivity to the study drug\n* Expect to die in the next 24 hours\n* Medical team not committed to full support at the time of inclusion\n* Previous inclusion in the study","ALL","18 Years",{"count":195,"type":196},2800,"ESTIMATED","INTERVENTIONAL",[199],"PHASE3","The norepinephrine and vasopressin for rescue versus early vasopressin for vasopressor dependent sepsis (NoVa) is a phase 3, multicenter, open-label, randomized controlled trial comparing an early vasopressin initiation strategy versus norepinephrine plus vasopressin initiation only as a rescue strategy for hemodynamic management of critically ill patients with vasopressor dependent sepsis.",[202],"Septic Shock",[204,205,206,207,208],"Vasopressin","Norepinephrine","Vasopressor dependent sepsis","Septic shock","Critically ill","2026-01-28",{"date":211,"type":212},"2026-01-30","ACTUAL",{"date":214,"type":212},"2024-11-21",{"date":216,"type":196},"2027-09",{"name":5,"class":6},8]