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Completed

NCT Number: NCT01747824

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in Altered Mental Status Score

    Time frame: Assessed every five minutes, from enrollment until discharge from the emergency department, an expected average time of 4 hours

  2. Change in Visual Analog Scale Pain Score

    Time frame: Assessed every five minutes, from enrollment until discharge from the emergency department, an expected average time of 4 hours

  3. Change in Serum Total Catecholamines

    Time frame: 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 outcomes

  1. Length of Hospital Stay

    Time frame: Assessed at time of discharge from the hospital, an expected average of 4 hours post enrollment.

  2. Mortality

    Time frame: Observed for 1 year post study enrollment

  3. Complications

    Time frame: Observed for 1 year post study enrollment

  4. Change in Heart Rate

    Time frame: Observed from time of enrollment until discharge from the emergency department, an expected average time of 4 hours

  5. Change in Systolic Blood Pressure

    Time frame: Observed from time of enrollment until discharge from the emergency department, an expected average time of 4 hours

  6. Change in Mean Arterial Pressure

    Time frame: Observed from time of enrollment until discharge from the emergency department, an expected average time of 4 hours

  7. Disposition

    Time frame: Assessed at discharge from the emergency department, an expected average of 4 hours post enrollment.

  8. Change in Body Temperature

    Time frame: Observed from time of enrollment until discharge from the emergency department, an expected average time of 4 hours

  9. Change in end tidal carbon dioxide

    Time frame: Assessed from time of enrollment until discharge from the emergency department, an expected average time of 4 hours

  10. Change in Oxygen Saturation

    Time frame: Observed from time of enrollment until discharge from the emergency department, an expected average time of 4 hours

Sponsors and collaborators

Lead sponsor

Hennepin Healthcare Research Institute

Other

Collaborators

  • U.S. Department of Justice

Registry information

Acronym: Agitation

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Dec 12, 2012
Registry last updated
Dec 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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