Norepinephrine and Vasopressin for Rescue Versus Early Vasopressin for Vasopressor Dependent Sepsis
NCT Number: NCT06464510
Acronym: NoVa
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Septic Shock
Interventions: DRUG: Early Vasopressin|DRUG: Norepinephrine and Vasopressin for Rescue
Sponsor: Hospital do Coracao
Collaborators: Brazilian Research in Intensive Care Network (BRICNet)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2800
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2027-09
Locations: Hospital Geral de Caxias do Sul, Caxias do Sul, RS, Brazil|Hospital Nereu Ramos, Florianópolis, Sc, Brazil|Hospital de Amor - Unidade Barretos (Fundação PIO XII), Barretos, SP, Brazil|Hospital Alemão Oswaldo Cruz, São Paulo, SP, Brazil|Hospital São Paulo - UNIFESP, São Paulo, SP, Brazil|Hospital Sírio-Libanês, São Paulo, SP, Brazil|Hospital SEPACO, São Paulo, S, Brazil|Hospital do Coracao, São Paulo, 05435000, Brazil|BP-A Beneficiência Portuguesa de São Paulo, São Paulo, Brazil

Summary:
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.

Primary Outcome Measures: All-cause mortality or renal replacement therapy, Composite of all-cause mortality or renal replacement therapy within 28 days after randomization., 28 days
Secondary Outcome Measures: All-cause mortality, All-cause mortality within 28 days after randomization, 28 days|Renal replacement-therapy, Need of renal replacement therapy within 28 days after randomization., 28 days|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., 28 days|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., 28 days|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., 28 days|Organ support-free days and its components, The definition of organ support involves three components: renal replacement therapy, invasive mechanical ventilation, and vasopressor use.

Organ 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., 28 days|Cardiac arrhythmias, Occurrence of cardiac arrhythmias between randomization and day 28, 28 days|Ischemic events, Occurrence of mesenteric ischemia, ischemic stroke, digital ischemia and acute coronary syndrome between randomization and day 28, 28 days