Prehospital Norepinephrine and Early Mortality in Traumatic Shock
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Prehospital norepinephrine Trauma patients that received norepinephrine in the prehospital setting or in the resuscitation unit . |
Drug: 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.
|
| Prehospital no norepinephrine Trauma patients that did not receive norepinephrine in the prehospital setting or in the resuscitation unit. |
Outcome Measures
Primary Outcome Measures
- Early mortality [Admission to the trauma center to 24-hours after admission]
Death within 24-hours of admission to the trauma center
Secondary Outcome Measures
- 28-day mortality [Admission to the trauma center to 28-days after admission]
Death occurring within 28-days from admission to the trauma center
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18-90 years
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Blunt traumatic mechanism of injury
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Admitted to the trauma center from the scene of injury
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Systolic blood pressure during prehospital transport or at admission to the trauma center <100 mmHg
Exclusion Criteria:
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Penetrating mechanism of injury
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No vital signs at the scene of injury
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Prehospital cardiac arrest
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Transferred to the trauma center from another hospital
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Maryland, Baltimore
- Beaujon Hospital
- University Grenoble Alps
Investigators
- Study Director: Tobias Gauss, MD, Hospital Beujon
- Study Director: Pierre Bouzat, MD, PhD, University Grenoble Alps
- Principal Investigator: Justin E Richards, MD, R Adams Cowley Shock Trauma Center
Study Documents (Full-Text)
None provided.More Information
Publications
- Beloncle F, Meziani F, Lerolle N, Radermacher P, Asfar P. Does vasopressor therapy have an indication in hemorrhagic shock? Ann Intensive Care. 2013 May 22;3(1):13. doi: 10.1186/2110-5820-3-13.
- Gupta B, Garg N, Ramachandran R. Vasopressors: Do they have any role in hemorrhagic shock? J Anaesthesiol Clin Pharmacol. 2017 Jan-Mar;33(1):3-8. doi: 10.4103/0970-9185.202185. Review.
- HP-00082182