DRUG
Early Vasopressin
Early Vasopressin group: Vasopressin up to 0.04U/min initiated after randomization.
Norepinephrine and Vasopressin for Rescue Versus Early Vasopressin for Vasopressor Dependent Sepsis
Status
Recruiting
Phase
Phase 3
Enrollment
2,800
Locations
8
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Full detailed description
Sepsis is defined as a life-threatening organ dysfunction caused by a dysregulated body response to infection. Its most severe form, septic shock, occurs when underlying circulatory and cellular metabolic abnormalities are pronounced, indicating greater severity and higher mortality. Vasopressor use is a cornerstone aspect in the treatment of critically ill patients with sepsis-associated hemodynamic dysfunction, with norepinephrine, a catecholamine, being the vasopressor of choice. Vasopressin is an endogenous peptide hormone with potential advantages over norepinephrine in a catecholamine-sparing strategy for treating sepsis-associated hemodynamic dysfunction. This is a phase 3, multicenter, open-label, randomized controlled trial. Adult patients with sepsis-associated hemodynamic dysfunction in the ICU may be eligible to participate. We aim to enroll 2,800 patients.
Interventions
Treatment arms and agents.
DRUG
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.
Timeline
From registration to results.
First posted
Jun 18, 2024
Study start
Nov 21, 2024
Primary completion
Aug 2027
Study completion
Sep 2027
Results posted
Not reported
Registry updated
Jan 30, 2026
Outcomes
What the study measures.
Primary outcomes
All-cause mortality or renal replacement therapy
Time frame · 28 days
Composite of all-cause mortality or renal replacement therapy within 28 days after randomization.
Secondary outcomes
All-cause mortality
Time frame · 28 days
All-cause mortality within 28 days after randomization
Renal replacement-therapy
Time frame · 28 days
Need of renal replacement therapy within 28 days after randomization.
Renal replacement-free days
Time frame · 28 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.
ICU-free days
Time frame · 28 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.
Hospital-free days
Time frame · 28 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.
Organ support-free days and its components
Time frame · 28 days
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.
Cardiac arrhythmias
Time frame · 28 days
Occurrence of cardiac arrhythmias between randomization and day 28
Ischemic events
Time frame · 28 days
Occurrence of mesenteric ischemia, ischemic stroke, digital ischemia and acute coronary syndrome between randomization and day 28
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- 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
Study locations
8 registered sites.
Brazil. Showing up to 24 locations stored in the fast local snapshot.
Hospital Geral de Caxias do Sul
Caxias do Sul, Rio Grande do Sul, Brazil
Hospital Nereu Ramos
Florianópolis, Santa Catarina, Brazil
Hospital SEPACO
São Paulo, S, Brazil
Hospital de Amor - Unidade Barretos (Fundação PIO XII)
Barretos, São Paulo, Brazil
Hospital do Coracao
São Paulo, São Paulo, Brazil
BP-A Beneficiência Portuguesa de São Paulo
São Paulo, São Paulo, Brazil
Hospital Alemão Oswaldo Cruz
São Paulo, São Paulo, Brazil
Hospital São Paulo - UNIFESP
São Paulo, São Paulo, Brazil
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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