AgitationAgitationNCT01747824
Stress Biomarkers Among Patients Undergoing Treatment for Excited Delirium and Severe Pain in the Emergency Department
An observational study of Agitation and Excited Delirium, run by Hennepin Healthcare Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Agitation, Excited Delirium, Pain
- How many people
- 1,322 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing treatment for acute agitation in the emergency department of an urban Level 1 Trauma Center.
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
About this study
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.
Read the 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.
- Conditions
- Agitation, Excited Delirium, Pain
- Keywords
- agitation, excited delirium, pain, unexplained-in-custody-death, UICD, visual analog scale, VAS, altered mental status, AMS
- Medical subject headings
- Psychomotor Agitation, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in Altered Mental Status Score
Measured: 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
Measured: 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.
Measured: 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
Measured: Assessed at time of discharge from the hospital, an expected average of 4 hours post enrollment.
Mortality
Measured: Observed for 1 year post study enrollment
Complications
Measured: Observed for 1 year post study enrollment
Change in Heart Rate
Measured: Observed from time of enrollment until discharge from the emergency department, an expected average time of 4 hours
Change in Systolic Blood Pressure
Measured: Observed from time of enrollment until discharge from the emergency department, an expected average time of 4 hours
Change in Mean Arterial Pressure
Measured: Observed from time of enrollment until discharge from the emergency department, an expected average time of 4 hours
Disposition
Measured: Assessed at discharge from the emergency department, an expected average of 4 hours post enrollment.
Change in Body Temperature
Measured: Observed from time of enrollment until discharge from the emergency department, an expected average time of 4 hours
Change in end tidal carbon dioxide
Measured: Assessed from time of enrollment until discharge from the emergency department, an expected average time of 4 hours
Change in Oxygen Saturation
Measured: Observed from time of enrollment until discharge from the emergency department, an expected average time of 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,322 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hennepin Healthcare Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Department of Justice
- Responsible party
- Sponsor
- Investigators
- James R Miner, MD, Principal investigator, Hennepin County Medical Center, Minneapolis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01747824
- Sponsor's protocol ID
- 12-3478
- Acronym
- Agitation
- Status last verified
- Dec 2015
- First submitted
- 4 Dec 2012
- Last updated
- 23 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30031556
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Biomarkers Among Patients Undergoing Treatment for Excited Delirium and Severe Pain in the Emergency Department
- ClinicalTrials.gov ID
- NCT01747824
- Acronym / sponsor ID
- Agitation / 12-3478
- Conditions
- Agitation, Excited Delirium, Pain
- Keywords
- agitation, excited delirium, pain, unexplained-in-custody-death, UICD, visual analog scale, VAS, altered mental status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,322 participants (actual)
- Lead sponsor
- Hennepin Healthcare Research InstituteUniversity, hospital or other
- Collaborators
- U.S. Department of Justice
- Study start
- Dec 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 12 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing treatment for acute agitation in the emergency department of an urban Level 1 Trauma Center.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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.
10 secondary outcomes
Length of Hospital Stay
Time frame: 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
Complications
Time frame: 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
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
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
Disposition
Time frame: 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
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
Change in Oxygen Saturation
Time frame: Observed from time of enrollment until discharge from the emergency department, an expected average time of 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2015.
- Derived from this study: PubMed 30031556Miner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James R Miner, MD principal investigator
Hennepin County Medical Center, Minneapolis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Agitation and Excited Delirium, run by Hennepin Healthcare Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01747824, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2015.