Prehospital Norepinephrine and Early Mortality in Traumatic Shock

Study Overview
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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.

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.

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

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

Intervention / Treatment
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* Drug: Norepinephrine


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prehospital norepinephrine<br>Trauma patients that received norepinephrine in the prehospital setting or in the resuscitation unit . | Drug: Norepinephrine<br>* 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.<br>|
| Prehospital no norepinephrine<br>Trauma patients that did not receive norepinephrine in the prehospital setting or in the resuscitation unit. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early mortality | Death within 24-hours of admission to the trauma center | Admission to the trauma center to 24-hours after admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day mortality | Death occurring within 28-days from admission to the trauma center | Admission to the trauma center to 28-days after admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypotension, norepinephrine, traumatic shock