Prehospital Norepinephrine and Early Mortality in Traumatic Shock

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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Key information

Conditions

Traumatic Shock Brain Diseases Brain Injuries Brain Injuries, Traumatic Cardiovascular Diseases Central Nervous System Diseases Craniocerebral Trauma Hemorrhage Hemorrhagic Shock Hypotension Hypotension and Shock Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Shock, Hemorrhagic Shock, Traumatic Trauma, Nervous System Traumatic Brain Injury Vascular Diseases Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

norepinephrine

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.

Primary outcomes

Early mortality

Time frame: Admission to the trauma center to 24-hours after admission

Death within 24-hours of admission to the trauma center

Secondary outcomes

28-day mortality

Time frame: Admission to the trauma center to 28-days after admission

Death occurring within 28-days from admission to the trauma center

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

Beaujon Hospital
University Grenoble Alps

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2018
Study completion: 2021
First posted: Aug 4, 2020
Registry last updated: Feb 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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