Prehospital Norepinephrine and Early Mortality in Traumatic Shock

Overview

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 Title of Study: “The Association of Norepinephrine Use in Pre-hospital Transport and Early Mortality in Hemorrhagic Shock”

Study Type

• Study Type: Observational
• Study Design
  • Time Perspective: Retrospective
• Study Primary Completion Date: December 31, 2018

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.

Interventions

• 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.

Arms, Groups and Cohorts

• Prehospital norepinephrine
  • Trauma patients that received norepinephrine in the prehospital setting or in the resuscitation unit .
• Prehospital no norepinephrine
  • Trauma patients that did not receive norepinephrine in the prehospital setting or in the resuscitation unit.

Clinical Trial Outcome Measures

Primary Measures

• 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 Measures

• 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • University of Maryland, Baltimore
• Collaborator
  • Beaujon Hospital
• Provider of Information About this Clinical Study
  • Principal Investigator: Justin Richards, Associate Professor of Anesthesiology – University of Maryland, Baltimore
• Overall Official(s)
  • Tobias Gauss, MD, Study Director, Hospital Beujon
  • Pierre Bouzat, MD, PhD, Study Director, University Grenoble Alps
  • Justin E Richards, MD, Principal Investigator, R Adams Cowley Shock Trauma Center

References

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.

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.

Citations Reporting on Results

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.

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.

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.