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

Completed

• Conditions: Agitation; Pain; Excited Delirium

• Registration Number: NCT01747824
• Lead Sponsor: Hennepin Healthcare Research Institute

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.

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-04
• Study First Submitted QC: 2012-12-10
• Study First Posted: 2012-12-12
• Status Verified: 2015-12
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2015-12-22
• Last Update Posted: 2015-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1322

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	Assessed every 30 minutes, from enrollment until discharge from the emergency department, an expected average time of 4 hours	Serum dopamine, serum epinephrine, and serum norepinephrine.

Secondary Outcome Measures

Name	Time	Method
Complications	Observed for 1 year post study enrollment
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
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
Disposition	Assessed at discharge from the emergency department, an expected average of 4 hours post enrollment.
Change in Mean Arterial Pressure	Observed from time of enrollment until discharge from the emergency department, an expected average time of 4 hours
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

Trial Locations

Locations (1)

Hennepin County Medical Center; 🇺🇸 Minneapolis, Minnesota, United States