NCT06464510 Norepinephrine and Vasopressin for Rescue Versus Early Vasopressin for Vasopressor Dependent Sepsis
| NCT ID | NCT06464510 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Hospital do Coracao |
| Condition | Septic Shock |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,800 participants |
| Start Date | 2024-11-21 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 2,800 participants in total. It began in 2024-11-21 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Bruno M Tomazini, MD
PRINCIPAL INVESTIGATOR
Hcor Research Institute
Frequently Asked Questions
Who can join the NCT06464510 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Septic Shock. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06464510 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 2,800 participants.
Is NCT06464510 currently recruiting?
Yes, NCT06464510 is actively recruiting participants. Contact the research team at btomazini@hcor.com.br for enrollment information.
Where is the NCT06464510 trial being conducted?
This trial is being conducted at Caxias do Sul, Brazil, Florianópolis, Brazil, São Paulo, Brazil, Barretos, Brazil and 4 additional locations.
Who is sponsoring the NCT06464510 clinical trial?
NCT06464510 is sponsored by Hospital do Coracao. The principal investigator is Bruno M Tomazini, MD at Hcor Research Institute. The trial plans to enroll 2,800 participants.