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Clinical Trials in Brazil / NCT06464510
Recruiting Phase 3

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

NCT06464510 · tracked via the Priya Life Science Brazil tracker
Phase
Phase 3
Started
2024-11-21
Last updated
2026-01-30

Condition(s) studied

Septic Shock

Investigational drug(s) / intervention(s)

Early VasopressinNorepinephrine and Vasopressin for Rescue

Early Vasopressin: Early Vasopressin group: Vasopressin up to 0.04U/min initiated after randomization.

Norepinephrine and Vasopressin for Rescue: Norepinephrine and Vasopressin for Rescue group: Vasopressin up to 0.04U/min initiated only if norepinephrine dose exceeds 0.5 μg/kg/min.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (8)

FacilityCityRegionStatus
Hospital Geral de Caxias do Sul Caxias do Sul Rio Grande do Sul Recruiting
Hospital Nereu Ramos Florianópolis Santa Catarina Recruiting
Hospital SEPACO São Paulo S Not Yet Recruiting
Hospital de Amor - Unidade Barretos (Fundação PIO XII) Barretos São Paulo Not Yet Recruiting
Hospital do Coracao São Paulo São Paulo Recruiting
BP-A Beneficiência Portuguesa de São Paulo São Paulo São Paulo Not Yet Recruiting
Hospital Alemão Oswaldo Cruz São Paulo São Paulo Not Yet Recruiting
Hospital São Paulo - UNIFESP São Paulo São Paulo Recruiting

More Hospital do Coracao trials in Brazil

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06464510 on ClinicalTrials.gov ↗ ← All trials in Brazil