Stress Biomarkers Among Patients Undergoing Treatment for Excited Delirium and Severe Pain in the Emergency Department

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1322 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2015-12-31

Brief Summary

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The purpose of this project is to determine the levels of stress biomarkers associated with severe pain, agitation from intoxication or psychosis, and excited delirium at various levels of the disease in order to compare them to pre-clinical models of law enforcement encounters. We hypothesize that the serum catecholamines and markers of metabolic acidosis will worsen with the duration and severity of agitation among agitated patients and will not worsen among patients with severe pain who are not agitated.

Specific Aims

* To assess the prevalence of patients undergoing treatment for agitation from any cause requiring restraint or sedation.
* To assess the prevalence of excited delirium in the emergency department.
* To determine the difference in serum total catecholamines, serum dopamine, serum epinephrine, serum norepinephrine, heart rate, systolic blood pressure, mean arterial pressure, mortality, and disposition among patients with agitation requiring restraint, including excited delirium and patients with severe pain from extremity fractures.
* To describe changes in stress biomarkers among patients with changing levels of agitation as determined by the Altered Mental Status scale.

Detailed Description

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In this study, we propose to study Emergency Department patients under physiologic stress from severe pain, agitation, drug overdose, and excited delirium in order to compare markers of acidosis in patients at risk for unexplained-in-custody-death (UICD) in order to determine the relationship of these markers to what has been found in simulated law enforcement encounters. This information will help clarify the levels of stress associated with arrest and restraint conditions, allowing us to determine what aspects and levels of stress may be associated with the fatal mechanisms of UICD, and to identify markers that would inform death investigators of the mechanism of UICD. At the conclusion of this project, we will be able to report details explaining the relationship of the physiologic and metabolic effects of stress from restraint in excited delirium to other peri-arrest conditions and our previous work in simulated law enforcement encounters.

Conditions

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Agitation Excited Delirium Pain

Keywords

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agitation excited delirium pain unexplained-in-custody-death UICD visual analog scale VAS altered mental status AMS

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Agitation Group

Patients that are evaluated to have an altered mental status score greater than 1 will be enrolled in the Agitation Group.

No interventions assigned to this group

Pain Group

Patients that report severe pain secondary to a long bone fracture or dislocation and report a visual analog scale pain score greater than 7 will be enrolled in the Pain Group.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients with agitation as defined by an Altered Mental Status Score of \>1, and who are in restraints or are given sedatives for treatment of agitation.

* Patients with an extremity fracture who report their pain as severe.

Exclusion Criteria

* Less than 18 years of age
* Suspected or confirmed pregnancy

* Less than 18 years of age
* Suspected or confirmed pregnancy
* Prisoner

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James R Miner, MD

Role: PRINCIPAL_INVESTIGATOR

Hennepin County Medical Center, Minneapolis

Locations

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Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

References

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Miner JR, Klein LR, Cole JB, Driver BE, Moore JC, Ho JD. The Characteristics and Prevalence of Agitation in an Urban County Emergency Department. Ann Emerg Med. 2018 Oct;72(4):361-370. doi: 10.1016/j.annemergmed.2018.06.001. Epub 2018 Jul 19.

Reference Type DERIVED

PMID: 30031556 (View on PubMed)

Other Identifiers

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12-3478

Identifier Type: -

Identifier Source: org_study_id