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Prehospital Norepinephrine and Early Mortality in Traumatic Shock

The Association of Norepinephrine Use in Pre-hospital Transport and Early Mortality in Hemorrhagic Shock

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04497155
Enrollment
2164
Registered
2020-08-04
Start date
2013-01-01
Completion date
2021-12-31
Last updated
2022-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemorrhagic Shock, Hypotension and Shock, Traumatic Brain Injury, Traumatic Shock

Keywords

hypotension, norepinephrine, traumatic shock

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.

Interventions

DRUGNorepinephrine

Trauma patients with prehospital or arrival to the trauma center hypotension, defined as a systolic blood pressure \<100 mmHg, that received norepinephrine during prehospital transport or in the resuscitation unit.

Sponsors

Beaujon Hospital
CollaboratorOTHER
University Grenoble Alps
CollaboratorOTHER
University of Maryland, Baltimore
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

* Age 18-90 years * Blunt traumatic mechanism of injury * Admitted to the trauma center from the scene of injury * Systolic blood pressure during prehospital transport or at admission to the trauma center \<100 mmHg

Exclusion criteria

* Penetrating mechanism of injury * No vital signs at the scene of injury * Prehospital cardiac arrest * Transferred to the trauma center from another hospital

Design outcomes

Primary

MeasureTime frameDescription
Early mortalityAdmission to the trauma center to 24-hours after admissionDeath within 24-hours of admission to the trauma center

Secondary

MeasureTime frameDescription
28-day mortalityAdmission to the trauma center to 28-days after admissionDeath occurring within 28-days from admission to the trauma center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026