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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01747824
Acronym
Agitation
Enrollment
1322
Registered
2012-12-12
Start date
2012-12-31
Completion date
2015-12-31
Last updated
2015-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Agitation, Excited Delirium, Pain

Keywords

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

Brief summary

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

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.

Interventions

None listed

Sponsors

U.S. Department of Justice
CollaboratorFED
Hennepin Healthcare Research Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Agitation Group 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. Agitation Group

Exclusion criteria

* Less than 18 years of age * Suspected or confirmed pregnancy Pain Group Inclusion Criteria: * Patients with an extremity fracture who report their pain as severe. Pain Group

Design outcomes

Primary

MeasureTime frameDescription
Change in Altered Mental Status ScoreAssessed every five minutes, from enrollment until discharge from the emergency department, an expected average time of 4 hours
Change in Visual Analog Scale Pain ScoreAssessed every five minutes, from enrollment until discharge from the emergency department, an expected average time of 4 hours
Change in Serum Total CatecholaminesAssessed every 30 minutes, from enrollment until discharge from the emergency department, an expected average time of 4 hoursSerum dopamine, serum epinephrine, and serum norepinephrine.

Secondary

MeasureTime frame
Change in Heart RateObserved from time of enrollment until discharge from the emergency department, an expected average time of 4 hours
Length of Hospital StayAssessed at time of discharge from the hospital, an expected average of 4 hours post enrollment.
MortalityObserved for 1 year post study enrollment
Change in Systolic Blood PressureObserved from time of enrollment until discharge from the emergency department, an expected average time of 4 hours
Change in Body TemperatureObserved from time of enrollment until discharge from the emergency department, an expected average time of 4 hours
Change in end tidal carbon dioxideAssessed from time of enrollment until discharge from the emergency department, an expected average time of 4 hours
Change in Oxygen SaturationObserved from time of enrollment until discharge from the emergency department, an expected average time of 4 hours
ComplicationsObserved for 1 year post study enrollment
DispositionAssessed at discharge from the emergency department, an expected average of 4 hours post enrollment.
Change in Mean Arterial PressureObserved from time of enrollment until discharge from the emergency department, an expected average time of 4 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026