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

NCT01747824 | Completed DMC

• 1 other identifier: 12-3478
• Study Type: observational
• Target: 1,322
• Locations: 1 country
• Sites: 1

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.

Conditions

Agitation; Excited Delirium; Pain

Keywords

agitation; excited delirium; pain; unexplained-in-custody-death; UICD; visual analog scale; VAS; altered mental status; AMS

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• 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

Study Arms (2)

Agitation Group

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

Pain Group

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing treatment for acute agitation in the emergency department of an urban Level 1 Trauma Center.

You may qualify if:

• 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.

You may not qualify if:

• Less than 18 years of age
• Suspected or confirmed pregnancy
• Patients with an extremity fracture who report their pain as severe.
• Less than 18 years of age
• Suspected or confirmed pregnancy
• Prisoner

Sponsors & Collaborators

• Hennepin Healthcare Research Institute: lead
• U.S. Department of Justice: collaborator

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Related Publications (1)

• 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.

  PMID: 30031556 DERIVED

MeSH Terms

Conditions

Psychomotor Agitation; Pain

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Study Officials

• James R Miner, MD

  Hennepin County Medical Center, Minneapolis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2012
• First Posted: December 12, 2012
• Study Start: December 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 23, 2015

Record last verified: 2015-12

Locations

US (1)