Prehospital Norepinephrine and Early Mortality in Traumatic Shock

NCT04497155 | Completed FDA Drug

• 1 other identifier: HP-00082182
• Study Type: observational
• Target: 2,164
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Traumatic Shock; Hemorrhagic Shock; Traumatic Brain Injury; Hypotension and Shock

Keywords

hypotension; norepinephrine; traumatic shock

Outcome Measures

Primary Outcomes (1)

• Early mortality

  Death within 24-hours of admission to the trauma center

  Admission to the trauma center to 24-hours after admission

Secondary Outcomes (1)

• 28-day mortality

  Admission to the trauma center to 28-days after admission

Study Arms (2)

Prehospital norepinephrine

Trauma patients that received norepinephrine in the prehospital setting or in the resuscitation unit .

Drug: Norepinephrine

Prehospital no norepinephrine

Trauma patients that did not receive norepinephrine in the prehospital setting or in the resuscitation unit.

Interventions

Norepinephrine DRUG

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 norepinephrine

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Penetrating mechanism of injury
• No vital signs at the scene of injury
• Prehospital cardiac arrest
• Transferred to the trauma center from another hospital

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Beaujon Hospital: collaborator
• University Grenoble Alps: collaborator

Related Publications (5)

• 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.

  PMID: 28413267 BACKGROUND

• 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.

  PMID: 23697682 BACKGROUND

• 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.

  PMID: 29793591 RESULT

• 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.

  PMID: 31461138 RESULT

• 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.

  PMID: 25782753 RESULT

MeSH Terms

Conditions

Shock, Traumatic; Shock, Hemorrhagic; Brain Injuries, Traumatic; Hypotension; Shock

Interventions

Norepinephrine

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Hemorrhage; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Tobias Gauss, MD

  Hospital Beujon

  STUDY DIRECTOR

• Pierre Bouzat, MD, PhD

  University Grenoble Alps

  STUDY DIRECTOR

• Justin E Richards, MD

  R Adams Cowley Shock Trauma Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 4, 2020
• Study Start: January 1, 2013
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2021
• Last Updated: February 10, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share