Norepinephrine and Vasopressin for Rescue Versus Early Vasopressin for Vasopressor Dependent Sepsis: An Open-label, Multicenter, Randomized, Controlled Trial: NoVa
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Patients with vasopressor dependent sepsis, defined by infection suspicion and antibiotic administration 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
Locations
Other Locations
Brazil
Hospital de Amor - Unidade Barretos (Fundação PIO XII)
NOT_YET_RECRUITING
Barretos
Hospital Geral de Caxias do Sul
RECRUITING
Caxias Do Sul
Hospital Nereu Ramos
RECRUITING
Florianópolis
BP-A Beneficiência Portuguesa de São Paulo
NOT_YET_RECRUITING
São Paulo
Hospital Alemão Oswaldo Cruz
NOT_YET_RECRUITING
São Paulo
Hospital do Coracao
RECRUITING
São Paulo
Hospital São Paulo - UNIFESP
RECRUITING
São Paulo
Hospital SEPACO
NOT_YET_RECRUITING
São Paulo
Contact Information
Primary
Bruno M Tomazini, MD
btomazini@hcor.com.br
+5511982839173
Backup
Alexandre Biasi Cavalcanti, PhD
abiasi@hcor.com.br
+551130536611
Time Frame
Start Date:2024-11-21
Estimated Completion Date:2027-09
Participants
Target number of participants:2800
Treatments
Experimental: Early Vasopressin
After 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.
Active_comparator: Norepinephrine plus vasopressin for rescue
After 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.