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

Study Overview
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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.

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

Conditions
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Agitation, Excited Delirium, Pain

Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: Less than 18 years of age Suspected or confirmed pregnancy Prisoner

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Agitation Group<br>Patients that are evaluated to have an altered mental status score greater than 1 will be enrolled in the Agitation Group. | |
| Pain Group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Altered Mental Status Score |  | Assessed every five minutes, from enrollment until discharge from the emergency department, an expected average time of 4 hours | 
| Change in Visual Analog Scale Pain Score |  | Assessed every five minutes, from enrollment until discharge from the emergency department, an expected average time of 4 hours | 
| Change in Serum Total Catecholamines | Serum dopamine, serum epinephrine, and serum norepinephrine. | Assessed every 30 minutes, from enrollment until discharge from the emergency department, an expected average time of 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Hospital Stay |  | Assessed at time of discharge from the hospital, an expected average of 4 hours post enrollment. | 
| Mortality |  | Observed for 1 year post study enrollment | 
| Complications |  | Observed for 1 year post study enrollment | 
| Change in Heart Rate |  | Observed from time of enrollment until discharge from the emergency department, an expected average time of 4 hours | 
| Change in Systolic Blood Pressure |  | Observed from time of enrollment until discharge from the emergency department, an expected average time of 4 hours | 
| Change in Mean Arterial Pressure |  | Observed from time of enrollment until discharge from the emergency department, an expected average time of 4 hours | 
| Disposition |  | Assessed at discharge from the emergency department, an expected average of 4 hours post enrollment. | 
| Change in Body Temperature |  | Observed from time of enrollment until discharge from the emergency department, an expected average time of 4 hours | 
| Change in end tidal carbon dioxide |  | Assessed from time of enrollment until discharge from the emergency department, an expected average time of 4 hours | 
| Change in Oxygen Saturation |  | Observed from time of enrollment until discharge from the emergency department, an expected average time of 4 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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agitation, excited delirium, pain, unexplained-in-custody-death, UICD, visual analog scale, VAS, altered mental status, AMS