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

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 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

Conditions2

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