Traumatic ShockNCT04497155
Prehospital Norepinephrine and Early Mortality in Traumatic Shock
An observational study of Traumatic Shock and Hemorrhagic Shock, run by University of Maryland, Baltimore.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Shock, Hemorrhagic Shock, Traumatic Brain Injury
- What is being tested?
- Norepinephrine
- How many people
- 2,164 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Penetrating mechanism of injury
- No vital signs at the scene of injury
- Prehospital cardiac arrest
- Transferred to the trauma center from another hospital
About this study
Official title: The Association of Norepinephrine Use in Pre-hospital Transport and Early Mortality in Hemorrhagic Shock
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.
Read the 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.
- Being tested
- Norepinephrine
- Keywords
- hypotension, norepinephrine, traumatic shock
- Medical subject headings
- Shock, Traumatic, Shock, Hemorrhagic, Brain Injuries, Traumatic, Hypotension, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NorepinephrineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Prehospital norepinephrine | Trauma patients that received norepinephrine in the prehospital setting or in the resuscitation unit . Receives: Drug: Norepinephrine | |
| Prehospital no norepinephrine | Trauma patients that did not receive norepinephrine in the prehospital setting or in the resuscitation unit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early mortality
Death within 24-hours of admission to the trauma center
Measured: Admission to the trauma center to 24-hours after admission
Secondary outcomes (1)
28-day mortality
Death occurring within 28-days from admission to the trauma center
Measured: Admission to the trauma center to 28-days after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start1 Jan 2013
- Primary completion31 Dec 2018
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Traumatic ShockStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,164 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Beaujon Hospital, University Grenoble Alps
- Responsible party
- Principal investigator, Justin Richards, University of Maryland, Baltimore
- Investigators
- Tobias Gauss, MD, Study director, Hospital BeujonPierre Bouzat, MD, PhD, Study director, University Grenoble AlpsJustin E Richards, MD, Principal investigator, R Adams Cowley Shock Trauma Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04497155
- Sponsor's protocol ID
- HP-00082182
- Status last verified
- Jan 2022
- First submitted
- 29 Jul 2020
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28413267Beloncle 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.
PubMed 23697682Gauss 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.
PubMed 29793591Sims 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.
PubMed 31461138Harrois 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.
PubMed 25782753
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of Norepinephrine Use in Pre-hospital Transport and Early Mortality in Hemorrhagic Shock
- ClinicalTrials.gov ID
- NCT04497155
- Acronym / sponsor ID
- HP-00082182
- Keywords
- hypotension, norepinephrine, traumatic shock
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,164 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Beaujon Hospital, University Grenoble Alps
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 4 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prehospital norepinephrine | – | Drug: NorepinephrineTrauma 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Penetrating mechanism of injury
- No vital signs at the scene of injury
- Prehospital cardiac arrest
- Transferred to the trauma center from another hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NorepinephrineTrauma 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. | Drug | Prehospital norepinephrine |
Primary outcome
Early mortality
Time frame: Admission to the trauma center to 24-hours after admission
Death within 24-hours of admission to the trauma center
1 secondary outcome
28-day mortality
Time frame: Admission to the trauma center to 28-days after admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
- Background: PubMed 28413267Gupta 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.
- Background: PubMed 23697682Beloncle 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.
- Results publication: PubMed 29793591Gauss 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.
- Results publication: PubMed 31461138Sims 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.
- Results publication: PubMed 25782753Harrois 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Shock and Hemorrhagic Shock, run by University of Maryland, Baltimore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early mortality (time frame: Admission to the trauma center to 24-hours after admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04497155, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2022.