Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06464510

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

Led by Hospital do Coracao · Updated on 2026-01-30

2800

Participants Needed

8

Research Sites

144 weeks

Total Duration

On this page

Sponsors

H

Hospital do Coracao

Lead Sponsor

B

Brazilian Research In Intensive Care Network

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with vasopressor dependent sepsis, defined by suspected infection with antibiotic use or confirmed viral infection plus low blood pressure needing vasopressors for at least one hour
  • Admitted or expected admission to the intensive care unit within 12 hours
  • Adequate fluid resuscitation as judged by the attending physician
  • Use of norepinephrine between 0.05 and 0.25 micrograms per kilogram per minute for at least 1 hour and no more than 24 hours at enrollment
Not Eligible

You will not qualify if you...

  • Use of norepinephrine above 0.25 micrograms per kilogram per minute in the last 24 hours, except transient use less than one hour for sedation or initial fluid resuscitation
  • Chronic kidney disease requiring dialysis or acute kidney injury needing or expected to need renal replacement therapy within 24 hours
  • Use of other vasopressors besides norepinephrine at enrollment
  • Use of vasopressors for sepsis in the last 7 days
  • Suspected or confirmed acute mesenteric ischemia
  • Anaphylaxis or known allergy to study drugs
  • Expected death within 24 hours
  • Medical team not committed to full support at enrollment
  • Previous participation in this study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 8 locations

1

Hospital Geral de Caxias do Sul

Caxias do Sul, Rio Grande do Sul, Brazil

Actively Recruiting

2

Hospital Nereu Ramos

Florianópolis, Santa Catarina, Brazil

Actively Recruiting

3

Hospital SEPACO

São Paulo, S, Brazil

Not Yet Recruiting

4

Hospital de Amor - Unidade Barretos (Fundação PIO XII)

Barretos, São Paulo, Brazil

Not Yet Recruiting

5

Hospital do Coracao

São Paulo, São Paulo, Brazil, 05435000

Actively Recruiting

6

BP-A Beneficiência Portuguesa de São Paulo

São Paulo, São Paulo, Brazil

Not Yet Recruiting

7

Hospital Alemão Oswaldo Cruz

São Paulo, São Paulo, Brazil

Not Yet Recruiting

8

Hospital São Paulo - UNIFESP

São Paulo, São Paulo, Brazil

Actively Recruiting

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Research Team

B

Bruno M Tomazini, MD

CONTACT

A

Alexandre Biasi Cavalcanti, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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