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

Hennepin Healthcare

Status: Completed

Conditions: Agitation; Excited Delirium; Pain

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01747824

12-3478

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,322 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 Exclusion Criteria:

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

Trial design

1,322 participants in 2 patient groups

Agitation Group

Description:

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

Pain Group

Description:

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.