Comparing early vasopressin to norepinephrine for treating septic shock
Norepinephrine and Vasopressin for Rescue Versus Early Vasopressin for Vasopressor Dependent Sepsis: An Open-label, Multicenter, Randomized, Controlled Trial: NoVa
This study is testing whether starting treatment with vasopressin right away is better than using norepinephrine plus vasopressin later for adults with severe sepsis who need help with their blood pressure.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 2800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital do Coracao Academic / other |
| Locations | 8 sites (Caxias do Sul, Rio Grande do Sul and 7 other locations) |
| Trial ID | NCT06464510 on ClinicalTrials.gov |
What this trial studies
This phase 3, multicenter, open-label, randomized controlled trial investigates the effectiveness of early vasopressin initiation versus a rescue strategy using norepinephrine plus vasopressin for critically ill patients suffering from vasopressor dependent sepsis. The study aims to enroll 2,800 adult patients who exhibit hemodynamic dysfunction due to sepsis. Participants will be monitored for their response to the different vasopressor strategies in managing their condition effectively.
Who should consider this trial
Good fit: Ideal candidates are adults with vasopressor dependent sepsis who require ICU admission and have received adequate volume resuscitation.
Not a fit: Patients who have received high doses of norepinephrine or those with severe kidney issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve hemodynamic management and outcomes for patients with septic shock.
How similar studies have performed: Other studies have explored vasopressor strategies in sepsis, but this specific comparison of early vasopressin versus norepinephrine as a rescue strategy is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Caxias do Sul, Rio Grande do Sul and 7 other locations
- Hospital Geral de Caxias do Sul — Caxias do Sul, Rio Grande do Sul, Brazil (Recruiting)
- Hospital Nereu Ramos — Florianópolis, Santa Catarina, Brazil (Recruiting)
- Hospital SEPACO — São Paulo, S, Brazil (Not_yet_recruiting)
- Hospital de Amor - Unidade Barretos (Fundação PIO XII) — Barretos, São Paulo, Brazil (Not_yet_recruiting)
- Hospital do Coracao — São Paulo, São Paulo, Brazil (Recruiting)
- BP-A Beneficiência Portuguesa de São Paulo — São Paulo, São Paulo, Brazil (Not_yet_recruiting)
- Hospital Alemão Oswaldo Cruz — São Paulo, São Paulo, Brazil (Not_yet_recruiting)
- Hospital São Paulo - UNIFESP — São Paulo, São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Bruno M Tomazini, MD — Hcor Research Institute
- Study coordinator: Bruno M Tomazini, MD
- Email: btomazini@hcor.com.br
- Phone: +5511982839173
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.