Norepinephrine and Vasopressin for Rescue Versus Early Vasopressin for Vasopressor Dependent Sepsis
NoVa
1 other identifier
interventional
2,800
1 country
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2024
Typical duration for phase_3
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2024
CompletedFirst Posted
Study publicly available on registry
June 18, 2024
CompletedStudy Start
First participant enrolled
November 21, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
January 30, 2026
March 1, 2025
2.7 years
June 11, 2024
January 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
All-cause mortality or renal replacement therapy
Composite of all-cause mortality or renal replacement therapy within 28 days after randomization.
28 days
Secondary Outcomes (8)
All-cause mortality
28 days
Renal replacement-therapy
28 days
Renal replacement-free days
28 days
ICU-free days
28 days
Hospital-free days
28 days
- +3 more secondary outcomes
Study Arms (2)
Early Vasopressin
EXPERIMENTALAfter randomization, vasopressin will be initiated and titrated up to 0.04U/min to maintain the target mean arterial pressure (MAP). Concurrently, norepinephrine will be reduced, with the goal of using the maximum dose of vasopressin and minimizing or eliminating the use of norepinephrine, while still maintaining the target MAP.
Norepinephrine plus vasopressin for rescue
ACTIVE COMPARATORAfter randomization, norepinephrine will be titrated to maintain the target MAP. Vasopressin will be introduced as a rescue strategy only if the norepinephrine dose exceeds 0.5 μg/kg/min. Once vasopressin is initiated, it can be titrated up to 0.04U/min to help maintain the target MAP if the norepinephrine dose remains above 0.5 μg/kg/min.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
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, 05435000, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bruno M Tomazini, MD
Hcor Research Institute
- STUDY CHAIR
Machado R Flavia, PhD
Universidade Federal de São Paulo
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2024
First Posted
June 18, 2024
Study Start
November 21, 2024
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
September 1, 2027
Last Updated
January 30, 2026
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 1 year after study publication
- Access Criteria
- Submission of a statistical analysis plan for the purposed analyses for the Steering Committee evaluation. Compliance with Brazilian data privacy law.
Submission of a statistical analysis plan for the purposed analyses for the Steering Committee evaluation. Compliance with Brazilian data privacy law.