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Randomized Controlled Trial of Dexmedetomidine for the Treatment of Intensive Care Unit (ICU) Delirium

Primary Purpose

Delirium, Agitation

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dexmedetomidine
Standard of Care
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Delirium focused on measuring Delirium, Agitation, Sedation, Dexmedetomidine, Surgical

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adults admitted to our surgical ICU who do not have any exclusion criteria Eligibility for treatment- Development of delirium as defined Exclusion Criteria: Acute MI (myocardial infarction), Trauma <24 hours, Head injury, Multiple organ failure, EF (ejection fraction) < 30%, History of hypersensitivity to alpha2 agonist, History of seizures, MAP (mean arterial pressure) <60 mm of Hg, Dysrhythmias a/with bradycardia (HR (heart rate) <50), Need for vasopressors, Acute renal failure with a need for dialysis/CVVH (Continuous Veno-Venous Hemofiltration) or liver disease. Women of child bearing age who do not have a documented negative pregnancy test and/or who do not actively use contraception. (Documented negative pregnancy test will be a urine pregnancy test obtained on this admission)

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Infusion of dexmedetomidine

Standard of Care

Arm Description

infusion 0.3-0.7 dexmedetomidine

Standard of care per treating physician preference

Outcomes

Primary Outcome Measures

Resolution of Delirium
Resolution of delirium as defined by 2 consecutive negative CAM-ICU assessments. The Confusion Assessment Method for the ICU (CAM-ICU). The CAM-ICU assesses the four features of delirium: feature 1 is an acute change in mental status or a fluctuating mental status, feature 2 is inattention, feature 3 is altered level of consciousness, and feature 4 is disorganized thinking.

Secondary Outcome Measures

Length of Ventilator Support
Number of days on mechanical ventilation
Length of Intensive Care Unit (ICU) Stay
Number of days intensive care unit (ICU) stay
Ease of Management for the Nursing Staff
Subjective measure rating 3 categories for ease of management: Mostly easy Easy to manage 75% of the time Not easy to manage
In-hospital Mortality
Did patient die while in the hospital? (Yes/No)

Full Information

First Posted
July 10, 2006
Last Updated
May 9, 2017
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00351299
Brief Title
Randomized Controlled Trial of Dexmedetomidine for the Treatment of Intensive Care Unit (ICU) Delirium
Official Title
Study of Dexmedetomidine as an Effective Sedative to Treat Acute ICU Delirium
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the research is to see if dexmedetomidine (a drug that has a calming effect - a sedative) is effective for the treatment of acute delirium
Detailed Description
Delirium is a mental disturbance that causes people to be confused and restless for a period of time. We will compare dexmedetomidine to the traditional therapy for treatment of acute delirium. Dexmedetomidine does not affect breathing. The traditional drugs might make one sleepy and may slow down breathing. The traditional therapy in this institution for acute delirium is _the use of Haloperidol, and/or benzodiazepines. Haloperidol is an antipsychotic drug that has calming effect. Benzodiazepines are sedatives with calming effect.Dexmedetomidine is approved by the Food and drug Administration (FDA) to sedate patients on a breathing machine for 24 hours.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium, Agitation
Keywords
Delirium, Agitation, Sedation, Dexmedetomidine, Surgical

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Infusion of dexmedetomidine
Arm Type
Experimental
Arm Description
infusion 0.3-0.7 dexmedetomidine
Arm Title
Standard of Care
Arm Type
Other
Arm Description
Standard of care per treating physician preference
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
dexmedetomidine infusion titrated to effect
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Standard of care per treating physician preference
Primary Outcome Measure Information:
Title
Resolution of Delirium
Description
Resolution of delirium as defined by 2 consecutive negative CAM-ICU assessments. The Confusion Assessment Method for the ICU (CAM-ICU). The CAM-ICU assesses the four features of delirium: feature 1 is an acute change in mental status or a fluctuating mental status, feature 2 is inattention, feature 3 is altered level of consciousness, and feature 4 is disorganized thinking.
Time Frame
Up to 7 days
Secondary Outcome Measure Information:
Title
Length of Ventilator Support
Description
Number of days on mechanical ventilation
Time Frame
Patients will remain in the study for up to 7 days after development of delirium or discharge from ICU whichever is earlier, up to study end
Title
Length of Intensive Care Unit (ICU) Stay
Description
Number of days intensive care unit (ICU) stay
Time Frame
Patients will remain in the study for up to 7 days after development of delirium or discharge from ICU whichever is earlier, up to study end
Title
Ease of Management for the Nursing Staff
Description
Subjective measure rating 3 categories for ease of management: Mostly easy Easy to manage 75% of the time Not easy to manage
Time Frame
Up to initial 48 hours
Title
In-hospital Mortality
Description
Did patient die while in the hospital? (Yes/No)
Time Frame
Patients will remain in the study for up to 7 days after development of delirium or discharge from ICU whichever is earlier, up to study end

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults admitted to our surgical ICU who do not have any exclusion criteria Eligibility for treatment- Development of delirium as defined Exclusion Criteria: Acute MI (myocardial infarction), Trauma <24 hours, Head injury, Multiple organ failure, EF (ejection fraction) < 30%, History of hypersensitivity to alpha2 agonist, History of seizures, MAP (mean arterial pressure) <60 mm of Hg, Dysrhythmias a/with bradycardia (HR (heart rate) <50), Need for vasopressors, Acute renal failure with a need for dialysis/CVVH (Continuous Veno-Venous Hemofiltration) or liver disease. Women of child bearing age who do not have a documented negative pregnancy test and/or who do not actively use contraception. (Documented negative pregnancy test will be a urine pregnancy test obtained on this admission)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerald L Weinhouse, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Randomized Controlled Trial of Dexmedetomidine for the Treatment of Intensive Care Unit (ICU) Delirium

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