Prehospital Norepinephrine and Early Mortality in Traumatic Shock

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2164 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-01

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Traumatic Shock Hemorrhagic Shock Traumatic Brain Injury Hypotension and Shock

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Prehospital norepinephrine

Trauma patients that received norepinephrine in the prehospital setting or in the resuscitation unit .

Norepinephrine

Intervention Type DRUG

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.

Prehospital no norepinephrine

Trauma patients that did not receive norepinephrine in the prehospital setting or in the resuscitation unit.

No interventions assigned to this group

Interventions

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Norepinephrine

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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes