Actively Recruiting
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
Eligibility Criteria
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
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
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
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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