Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05774054
Status:
COMPLETED
Last Update Posted:
2023-03-24
First Post:
2023-03-07
Brief Title:
The Impact of Early Norepinephrine Administration on Outcomes of Patients With Sepsis-induced Hypotension
Sponsor:
Tanta University
Organization:
Tanta University
Study Overview
Official Title:
The Impact of Early Norepinephrine Administration on Outcomes of Patients With Sepsis-induced Hypotension
Status:
COMPLETED
Status Verified Date:
2023-03
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:
None
Brief Summary:
Septic shock is defined as sepsis with persistent hypotension requiring vasopressors to maintain mean arterial pressure MAP 65 mmHg and a serum lactate level of 2 mmolL 18 mgdL despite sufficient volume resuscitation
Hypovolemia both relative and absolute and reduced vascular tone have a role in determining the severity of hypotension in septic shock
Hypovolemia both relative and absolute and reduced vascular tone have a role in determining the severity of hypotension in septic shock
Detailed Description:
Septic shock is defined as sepsis with persistent hypotension requiring vasopressors to maintain mean arterial pressure MAP 65 mmHg and a serum lactate level of 2 mmolL 18 mgdL despite sufficient volume resuscitation Hypovolemia both relative and absolute and reduced vascular tone have a role in determining the severity of hypotension in septic shock
When mean arterial pressure MAP falls below a specific critical level organ blood flow is physiologically dependent on perfusion pressure Fluid resuscitation and vasopressors have an influence on hypovolemia and the vascular tone in the early phase as fluid resuscitation aims to correct hypovolemia and vasopressors-norepinephrine NE- as a first-line drug aiming to restore vascular tone to assure organ perfusion
Norepinephrine is both an alpha1- and beta1-agonist so it is able to increase vascular tone and contractility
Nevertheless a large amount of fluids will increase the risk of fluid overload which is a common complication during septic shock resuscitation
After the early phase only fifty percent of patients respond to fluid administration meaning that fluid treatment cannot boost cardiac output CO The current data indicate that the time from the onset of septic shock to the initiation of norepinephrine administration is a significant survival predictor however a suggestion for the optimal time to provide norepinephrine support was not explicitly expressed
When mean arterial pressure MAP falls below a specific critical level organ blood flow is physiologically dependent on perfusion pressure Fluid resuscitation and vasopressors have an influence on hypovolemia and the vascular tone in the early phase as fluid resuscitation aims to correct hypovolemia and vasopressors-norepinephrine NE- as a first-line drug aiming to restore vascular tone to assure organ perfusion
Norepinephrine is both an alpha1- and beta1-agonist so it is able to increase vascular tone and contractility
Nevertheless a large amount of fluids will increase the risk of fluid overload which is a common complication during septic shock resuscitation
After the early phase only fifty percent of patients respond to fluid administration meaning that fluid treatment cannot boost cardiac output CO The current data indicate that the time from the onset of septic shock to the initiation of norepinephrine administration is a significant survival predictor however a suggestion for the optimal time to provide norepinephrine support was not explicitly expressed
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?:
False
Is an FDA AA801 Violation?:
None