Prehospital Norepinephrine and Early Mortality in Traumatic Shock

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04497155
• Other study ID #: HP-00082182
• Status: Completed
• Start date: January 1, 2013
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2022
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2164
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Hemorrhagic Shock
• Hypotension
• Hypotension and Shock
• Shock
• Shock, Hemorrhagic
• Shock, Traumatic
• Traumatic Brain Injury
• Traumatic Shock

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	Beaujon Hospital, University Grenoble Alps

References & Publications (5)

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. — View 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 Médicale Urgente. Effect of early use of noradrenaline on in-hospital mortality in haemorrhagic sh — View 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. Review. — View 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 Shoc — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early mortality	Death within 24-hours of admission to the trauma center	Admission to the trauma center to 24-hours after admission
Secondary	28-day mortality	Death occurring within 28-days from admission to the trauma center	Admission to the trauma center to 28-days after admission