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Norepinephrine and Vasopressin for Rescue Versus Early Vasopressin for Vasopressor Dependent Sepsis: An Open-label, Multicenter, Randomized, Controlled Trial: NoVa
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
November 21, 2024
Primary Completion Date
August 1, 2027
Completion Date
September 1, 2027
Last Updated
January 30, 2026
2,800
ESTIMATED participants
Early Vasopressin
DRUG
Norepinephrine and Vasopressin for Rescue
DRUG
Lead Sponsor
Hospital do Coracao
Collaborators
NCT07179276
NCT07383103
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07388628