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Norepinephrine and Vasopressin for Rescue Versus Early Vasopressin for Vasopressor Dependent Sepsis

RecruitingPhase 3Ages 18 Years - anyAllHospital do Coracao
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 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; * Admitted or expected to be admitted to the ICU in the next 12 hours * Adequate volume resuscitation in the opinion of the attending physician * Use of norepinephrine \> 0.05μg/Kg/min and ≤ 0.25μg/Kg/min for at least 1 hour and at most 24 hours at the time of inclusion Exclusion Criteria: * Use of norepinephrine \> 0.25μg/Kg/min 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 * 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 * Use of other vasopressors (except norepinephrine) at the moment of inclusion * Use of vasopressors for sepsis in the last 7 days * Suspected or confirmed acute mesenteric ischemia * Anaphylaxis or known hypersensitivity to the study drug * Expect to die in the next 24 hours * Medical team not committed to full support at the time of inclusion * Previous inclusion in the study
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What it tests

  • Early Vasopressin
  • Norepinephrine and Vasopressin for Rescue
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Where

8 sites
Hospital Geral de Caxias do Sul
Caxias do Sul, Brazil
Hospital Nereu Ramos
Florianópolis, Brazil
Hospital SEPACO
São Paulo, Brazil
Hospital de Amor - Unidade Barretos (Fundação PIO XII)
Barretos, Brazil
Hospital do Coracao
São Paulo, Brazil
BP-A Beneficiência Portuguesa de São Paulo
São Paulo, Brazil
Hospital Alemão Oswaldo Cruz
São Paulo, Brazil
Hospital São Paulo - UNIFESP
São Paulo, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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