Norepinephrine and Vasopressin for Rescue Versus Early Vasopressin for Vasopressor Dependent Sepsis
ConditionSeptic Shock
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital do Coracao
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Early Vasopressin
- Norepinephrine and Vasopressin for Rescue
Treatment groups
2,800 Participants
are divided into 2 treatment groupsSponsors and collaborators
Hospital do Coracao
Lead sponsor
Brazilian Research In Intensive Care Network
Collaborator
National Institute of Science and Technology (INCT) in Precision Intensive Care Medicine
Collaborator
Source ClinicalTrials.gov