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

December 22, 2015 updated by: Hennepin Healthcare Research Institute

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

1322

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: Assessed every five minutes, from enrollment until discharge from the emergency department, an expected average time of 4 hours
Assessed every five minutes, from enrollment until discharge from the emergency department, an expected average time of 4 hours
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.
Assessed every 30 minutes, from enrollment until discharge from the emergency department, an expected average time of 4 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Length of Hospital Stay
Time Frame: Assessed at time of discharge from the hospital, an expected average of 4 hours post enrollment.
Assessed at time of discharge from the hospital, an expected average of 4 hours post enrollment.
Mortality
Time Frame: Observed for 1 year post study enrollment
Observed for 1 year post study enrollment
Complications
Time Frame: Observed for 1 year post study enrollment
Observed for 1 year post study enrollment
Change in Heart Rate
Time Frame: Observed from time of enrollment until discharge from the emergency department, an expected average time of 4 hours
Observed from time of enrollment until discharge from the emergency department, an expected average time of 4 hours
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
Observed from time of enrollment until discharge from the emergency department, an expected average time of 4 hours
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
Observed from time of enrollment until discharge from the emergency department, an expected average time of 4 hours
Disposition
Time Frame: Assessed at discharge from the emergency department, an expected average of 4 hours post enrollment.
Assessed at discharge from the emergency department, an expected average of 4 hours post enrollment.
Change in Body Temperature
Time Frame: Observed from time of enrollment until discharge from the emergency department, an expected average time of 4 hours
Observed from time of enrollment until discharge from the emergency department, an expected average time of 4 hours
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
Assessed from time of enrollment until discharge from the emergency department, an expected average time of 4 hours
Change in Oxygen Saturation
Time Frame: Observed from time of enrollment until discharge from the emergency department, an expected average time of 4 hours
Observed from time of enrollment until discharge from the emergency department, an expected average time of 4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hennepin Healthcare Research Institute

Collaborators

U.S. Department of Justice

Investigators

  • Principal Investigator: James R Miner, MD, Hennepin County Medical Center, Minneapolis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

December 4, 2012

First Submitted That Met QC Criteria

December 10, 2012

First Posted (Estimate)

December 12, 2012

Study Record Updates

Last Update Posted (Estimate)

December 23, 2015

Last Update Submitted That Met QC Criteria

December 22, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-3478

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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