Norepinephrine and Vasopressin for Rescue Versus Early Vasopressin for Vasopressor Dependent Sepsis
Recruiting
Phase 3Interventional Study
Septic Shock
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
2,800 (estimated)
Sponsor
Hospital do Coracao · Other
Who this trial is looking for
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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.
Trial Locations
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Eligibility Criteria
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 …
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
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