Ignite Creation Date:
2024-05-06 @ 3:00 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04497155
Status:
COMPLETED
Last Update Posted:
2022-02-10
First Post:
2020-07-29
Brief Title:
Prehospital Norepinephrine and Early Mortality in Traumatic Shock
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
The Association of Norepinephrine Use in Pre-hospital Transport and Early Mortality in Hemorrhagic Shock
Status:
COMPLETED
Status Verified Date:
2022-01
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:
The effect of early prehospital norepinephrine use in patients with traumatic shock on mortality is unknown Recent existing observational evidence from single system data US France Japan are conflicting The investigators hypothesize that prehospital norepinephrine is associated with decreased mortality when used in patients with traumatic shock
Detailed Description:
Prehospital hypotension is associated with worse clinical outcomes in patients who sustain traumatic injuries Administration of vasoactive medications including norepinephrine is not advocated in North American trauma systems due to the belief that vasopressors will worsen clinical outcomes and increase mortality However in European trauma systems prehospital vasopressor administration is included as part of the guidelines for the management of hypotension and hemorrhagic shock There are multiple physiologic explanations for why prehospital vasopressor administration may be useful in patients with traumatic shock such as providing adequate blood pressure to maintain vital signs until arrival at the trauma center allowing adequate organ perfusion in the setting of low blood flow and supplementing decreased hormone production in the later stages of hemorrhagic shock
The purpose of this retrospective study is to investigate if prehospital norepinephrine administration is associated with decreased mortality in patients with traumatic shock The investigators will collect patient data from previously collected sources of information and trauma databases from three separate locations the TRAUMABase consortium in Paris France TRENAU trauma database from Grenoble France and the R Adams Cowley Shock Trauma Center in Baltimore MD USA The investigators will perform statistical modeling to propensity score match patients that received prehospital vasopressors with patients that did not receive prehospital vasopressors and assess the association with 24-hour and 28-day mortality
The purpose of this retrospective study is to investigate if prehospital norepinephrine administration is associated with decreased mortality in patients with traumatic shock The investigators will collect patient data from previously collected sources of information and trauma databases from three separate locations the TRAUMABase consortium in Paris France TRENAU trauma database from Grenoble France and the R Adams Cowley Shock Trauma Center in Baltimore MD USA The investigators will perform statistical modeling to propensity score match patients that received prehospital vasopressors with patients that did not receive prehospital vasopressors and assess the association with 24-hour and 28-day mortality
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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