Norepinephrine and Vasopressin for Rescue Versus Early Vasopressin for Vasopressor Dependent Sepsis
Norepinephrine and Vasopressin for Rescue Versus Early Vasopressin for Vasopressor Dependent Sepsis: An Open-label, Multicenter, Randomized, Controlled Trial: NoVa
Hospital do Coracao
2,800 participants
Nov 21, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria9
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Early Vasopressin group: Vasopressin up to 0.04U/min initiated after randomization.
Norepinephrine and Vasopressin for Rescue group: Vasopressin up to 0.04U/min initiated only if norepinephrine dose exceeds 0.5 μg/kg/min.
Locations(8)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06464510