Ignite Creation Date:
2024-07-17 @ 11:05 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06464510
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-06-11
Brief Title:
Norepinephrine and Vasopressin for Rescue Versus Early Vasopressin for Vasopressor Dependent Sepsis
Sponsor:
Hospital do Coracao
Organization:
Hospital do Coracao
Study Overview
Official Title:
Norepinephrine and Vasopressin for Rescue Versus Early Vasopressin for Vasopressor Dependent Sepsis An Open-label Multicenter Randomized Controlled Trial NoVa
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NoVa
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
Detailed Description:
Sepsis is defined as a life-threatening organ dysfunction caused by a dysregulated body response to infection Its most severe form septic shock occurs when underlying circulatory and cellular metabolic abnormalities are pronounced indicating greater severity and higher mortality Vasopressor use is a cornerstone aspect in the treatment of critically ill patients with sepsis-associated hemodynamic dysfunction with norepinephrine a catecholamine being the vasopressor of choice
Vasopressin is an endogenous peptide hormone with potential advantages over norepinephrine in a catecholamine-sparing strategy for treating sepsis-associated hemodynamic dysfunction
This is a phase 3 multicenter open-label randomized controlled trial Adult patients with sepsis-associated hemodynamic dysfunction in the ICU may be eligible to participate We aim to enroll 2800 patients
Vasopressin is an endogenous peptide hormone with potential advantages over norepinephrine in a catecholamine-sparing strategy for treating sepsis-associated hemodynamic dysfunction
This is a phase 3 multicenter open-label randomized controlled trial Adult patients with sepsis-associated hemodynamic dysfunction in the ICU may be eligible to participate We aim to enroll 2800 patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None