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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Minneapolis Medical Research Foundation
Sponsor:
Collaborator:
U.S. Department of Justice
Information provided by (Responsible Party):
Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier:
NCT01747824
First received: December 4, 2012
Last updated: October 23, 2014
Last verified: October 2014
  Purpose

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.

Condition
Agitation
Excited Delirium
Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Stress Biomarkers Among Patients Undergoing Treatment for Excited Delirium and Severe Pain in the Emergency Department

Resource links provided by NLM:


Further study details as provided by Minneapolis Medical Research Foundation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    Serum dopamine, serum epinephrine, and serum norepinephrine.


Secondary Outcome Measures:
  • Length of Hospital Stay [ Time Frame: Assessed at time of discharge from the hospital, an expected average of 4 hours post enrollment. ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: Observed for 1 year post study enrollment ] [ Designated as safety issue: No ]
  • Complications [ Time Frame: Observed for 1 year post study enrollment ] [ Designated as safety issue: No ]
  • Change in Heart Rate [ Time Frame: Observed from time of enrollment until discharge from the emergency department, an expected average time of 4 hours ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Disposition [ Time Frame: Assessed at discharge from the emergency department, an expected average of 4 hours post enrollment. ] [ Designated as safety issue: No ]
  • Change in Body Temperature [ Time Frame: Observed from time of enrollment until discharge from the emergency department, an expected average time of 4 hours ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change in Oxygen Saturation [ Time Frame: Observed from time of enrollment until discharge from the emergency department, an expected average time of 4 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: December 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01747824

Contacts
Contact: James R Miner, MD 6128738791 Miner015@umn.edu

Locations
United States, Minnesota
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: James R Miner, MD    612-873-8791    miner015@umn.edu   
Principal Investigator: James R Miner, MD         
Sponsors and Collaborators
Minneapolis Medical Research Foundation
U.S. Department of Justice
Investigators
Principal Investigator: James R Miner, MD Hennepin County Medical Center, Minneapolis
  More Information

No publications provided

Responsible Party: Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier: NCT01747824     History of Changes
Other Study ID Numbers: 12-3478
Study First Received: December 4, 2012
Last Updated: October 23, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Minneapolis Medical Research Foundation:
agitation
excited delirium
pain
unexplained-in-custody-death
UICD
visual analog scale
VAS
altered mental status
AMS

Additional relevant MeSH terms:
Delirium
Confusion
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on November 19, 2014