Clinical trial NCT04497155: Prehospital Norepinephrine and Early Mortality in Traumatic Shock
Official title: The Association of Norepinephrine Use in Pre-hospital Transport and Early Mortality in Hemorrhagic Shock
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Shock
Hemorrhagic Shock
Traumatic Brain Injury
Hypotension and Shock
Keywords: hypotension
norepinephrine
traumatic shock
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: Beaujon Hospital
name: University Grenoble Alps
First posted: 2020-08-04
Enrollment: 2164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be collected from the previously collected trauma database at three separate locations, as previously described. These databases are collected, maintained, and managed by professional medical staff.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Early mortality
timeFrame: Admission to the trauma center to 24-hours after admission
Secondary outcomes:
measure: 28-day mortality
timeFrame: Admission to the trauma center to 28-days after admission
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Beujon
name: Tobias Gauss, MD
role: STUDY_DIRECTOR
affiliation: University Grenoble Alps
name: Pierre Bouzat, MD, PhD
role: STUDY_DIRECTOR
affiliation: R Adams Cowley Shock Trauma Center
name: Justin E Richards, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Gauss T, Gayat E, Harrois A, Raux M, Follin A, Daban JL, Cook F, Hamada S; TraumaBase Group; Prehospital Traumabase Group Ile de France, SAMU=Service d'Aide Medicale Urgente. Effect of early use of noradrenaline on in-hospital mortality in haemorrhagic shock after major trauma: a propensity-score analysis. Br J Anaesth. 2018 Jun;120(6):1237-1244. doi: 10.1016/j.bja.2018.02.032. Epub 2018 Apr 14.
citation: Sims CA, Holena D, Kim P, Pascual J, Smith B, Martin N, Seamon M, Shiroff A, Raza S, Kaplan L, Grill E, Zimmerman N, Mason C, Abella B, Reilly P. Effect of Low-Dose Supplementation of Arginine Vasopressin on Need for Blood Product Transfusions in Patients With Trauma and Hemorrhagic Shock: A Randomized Clinical Trial. JAMA Surg. 2019 Nov 1;154(11):994-1003. doi: 10.1001/jamasurg.2019.2884.
citation: Harrois A, Baudry N, Huet O, Kato H, Dupic L, Lohez M, Ziol M, Vicaut E, Duranteau J. Norepinephrine Decreases Fluid Requirements and Blood Loss While Preserving Intestinal Villi Microcirculation during Fluid Resuscitation of Uncontrolled Hemorrhagic Shock in Mice. Anesthesiology. 2015 May;122(5):1093-102. doi: 10.1097/ALN.0000000000000639.