Clinical trial NCT01747824: Stress Biomarkers Among Patients Undergoing Treatment for Excited Delirium and Severe Pain in the Emergency Department
Official title: Stress Biomarkers Among Patients Undergoing Treatment for Excited Delirium and Severe Pain in the Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Agitation
Excited Delirium
Pain
Keywords: agitation
excited delirium
pain
unexplained-in-custody-death
UICD
visual analog scale
VAS
altered mental status
AMS
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
Collaborators: name: U.S. Department of Justice
First posted: 2012-12-12
Enrollment: 1322
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing treatment for acute agitation in the emergency department of an urban Level 1 Trauma Center.

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.

Eligibility 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

Primary outcomes:
measure: Change in Altered Mental Status Score
timeFrame: Assessed every five minutes, from enrollment until discharge from the emergency department, an expected average time of 4 hours
measure: Change in Visual Analog Scale Pain Score
timeFrame: Assessed every five minutes, from enrollment until discharge from the emergency department, an expected average time of 4 hours
measure: Change in Serum Total Catecholamines
timeFrame: Assessed every 30 minutes, from enrollment until discharge from the emergency department, an expected average time of 4 hours
Secondary outcomes:
measure: Length of Hospital Stay
timeFrame: Assessed at time of discharge from the hospital, an expected average of 4 hours post enrollment.
measure: Mortality
timeFrame: Observed for 1 year post study enrollment
measure: Complications
timeFrame: Observed for 1 year post study enrollment
measure: Change in Heart Rate
timeFrame: Observed from time of enrollment until discharge from the emergency department, an expected average time of 4 hours
measure: Change in Systolic Blood Pressure
timeFrame: Observed from time of enrollment until discharge from the emergency department, an expected average time of 4 hours
measure: Change in Mean Arterial Pressure
timeFrame: Observed from time of enrollment until discharge from the emergency department, an expected average time of 4 hours
measure: Disposition
timeFrame: Assessed at discharge from the emergency department, an expected average of 4 hours post enrollment.
measure: Change in Body Temperature
timeFrame: Observed from time of enrollment until discharge from the emergency department, an expected average time of 4 hours
measure: Change in end tidal carbon dioxide
timeFrame: Assessed from time of enrollment until discharge from the emergency department, an expected average time of 4 hours
measure: Change in Oxygen Saturation
timeFrame: Observed from time of enrollment until discharge from the emergency department, an expected average time of 4 hours
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
Study officials:
affiliation: Hennepin County Medical Center, Minneapolis
name: James R Miner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miner JR, Klein LR, Cole JB, Driver BE, Moore JC, Ho JD. The Characteristics and Prevalence of Agitation in an Urban County Emergency Department. Ann Emerg Med. 2018 Oct;72(4):361-370. doi: 10.1016/j.annemergmed.2018.06.001. Epub 2018 Jul 19.