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

NCT06464510 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2800

Last updated 2026-01-30

No results posted yet for this study

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.

Conditions

  • Septic Shock

Interventions

DRUG

Early Vasopressin

Early Vasopressin group: Vasopressin up to 0.04U/min initiated after randomization.

DRUG

Norepinephrine and Vasopressin for Rescue

Norepinephrine and Vasopressin for Rescue group: Vasopressin up to 0.04U/min initiated only if norepinephrine dose exceeds 0.5 μg/kg/min.

Sponsors & Collaborators

  • Brazilian Research in Intensive Care Network (BRICNet)

    collaborator UNKNOWN

  • National Institute of Science and Technology (INCT) in Precision Intensive Care Medicine

    collaborator UNKNOWN

  • Hospital do Coracao

    lead OTHER

Principal Investigators

  • Bruno M Tomazini, MD · Hcor Research Institute

  • Machado R Flavia, PhD · Universidade Federal de São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-21
Primary Completion
2027-08-31
Completion
2027-09-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06464510 on ClinicalTrials.gov