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Prehospital Norepinephrine and Early Mortality in Traumatic Shock

University of Maryland Baltimore (UMB) logo

University of Maryland Baltimore (UMB)

Status

Completed

Conditions

Traumatic Brain Injury
Hemorrhagic Shock
Hypotension and Shock
Traumatic Shock

Treatments

Drug: Norepinephrine

Study type

Observational

Funder types

Other

Identifiers

NCT04497155
HP-00082182

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,164 patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

2,164 participants in 2 patient groups

Prehospital norepinephrine
Description:
Trauma patients that received norepinephrine in the prehospital setting or in the resuscitation unit .
Treatment:
Drug: Norepinephrine
Prehospital no norepinephrine
Description:
Trauma patients that did not receive norepinephrine in the prehospital setting or in the resuscitation unit.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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