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

Pain Clinical Trial

— Agitation  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01747824
• Other study ID #: 12-3478
• Status: Completed
• Phase: N/A
• First received: December 4, 2012
• Last updated: December 22, 2015
• Start date: December 2012
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Minneapolis Medical Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1322
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Agitation
• Delirium
• Excited Delirium
• Pain

Locations

Country	Name	City	State
United States	Hennepin County Medical Center	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Minneapolis Medical Research Foundation	U.S. Department of Justice

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Length of Hospital Stay		Assessed at time of discharge from the hospital, an expected average of 4 hours post enrollment.	No
Secondary	Mortality		Observed for 1 year post study enrollment	No
Secondary	Complications		Observed for 1 year post study enrollment	No
Secondary	Change in Heart Rate		Observed from time of enrollment until discharge from the emergency department, an expected average time of 4 hours	No
Secondary	Change in Systolic Blood Pressure		Observed from time of enrollment until discharge from the emergency department, an expected average time of 4 hours	No
Secondary	Change in Mean Arterial Pressure		Observed from time of enrollment until discharge from the emergency department, an expected average time of 4 hours	No
Secondary	Disposition		Assessed at discharge from the emergency department, an expected average of 4 hours post enrollment.	No
Secondary	Change in Body Temperature		Observed from time of enrollment until discharge from the emergency department, an expected average time of 4 hours	No
Secondary	Change in end tidal carbon dioxide		Assessed from time of enrollment until discharge from the emergency department, an expected average time of 4 hours	No
Secondary	Change in Oxygen Saturation		Observed from time of enrollment until discharge from the emergency department, an expected average time of 4 hours	No