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

• Sponsor: Brigham and Women's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00351299
• Collaborator: (none)
• Enrollment: 53
• Location: 1
• Arms: 2
• Duration (Months): 81
• Patients Per Site Per Month: 0.7

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Delirium; Agitation	Drug: Dexmedetomidine; Other: Standard of Care	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 53 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Study of Dexmedetomidine as an Effective Sedative to Treat Acute ICU Delirium
• Study Start Date: Jan 1, 2006
• Actual Primary Completion Date: Oct 1, 2012
• Actual Study Completion Date: Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Infusion of dexmedetomidine infusion 0.3-0.7 dexmedetomidine	Drug: Dexmedetomidine; dexmedetomidine infusion titrated to effect; Other Names: Precedex
Other: Standard of Care Standard of care per treating physician preference	Other: Standard of Care; Standard of care per treating physician preference

Outcome Measures

Primary Outcome Measures

1. Resolution of Delirium [Up to 7 days]

   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

1. Length of Ventilator Support [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]

   Number of days on mechanical ventilation

2. Length of Intensive Care Unit (ICU) Stay [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]

   Number of days intensive care unit (ICU) stay

3. Ease of Management for the Nursing Staff [Up to initial 48 hours]

   Subjective measure rating 3 categories for ease of management: Mostly easy Easy to manage 75% of the time Not easy to manage

4. In-hospital Mortality [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]

   Did patient die while in the hospital? (Yes/No)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hospital	Boston	Massachusetts	United States	02118

Sponsors and Collaborators

• Brigham and Women's Hospital

Investigators

• Principal Investigator: Gerald L Weinhouse, MD, Brigham and Women's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gerald L. Weinhouse, Staff Physician, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT00351299
• Other Study ID Numbers: 2005-P-001786, BWH
• First Posted: Jul 12, 2006
• Last Update Posted: Jun 9, 2017
• Last Verified: May 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Gerald L. Weinhouse, Staff Physician, Brigham and Women's Hospital: Delirium; Agitation; Sedation; Dexmedetomidine; Surgical
• Additional relevant MeSH terms: Delirium; Psychomotor Agitation; Dexmedetomidine

Study Results

Participant Flow

Recruitment Details	Patients admitted to ICU from 2005-2008
Pre-assignment Detail	Patients enrolled and randomized upon admission to ICU but treated with dexmedetomidine or standard of caremodalities only if they developed delirium.

Arm/Group Title	Infusion of Dexmedetomidine	Standard of Care
Arm/Group Description	infusion 0.2-0.7 dexmedetomidine Dexmedetomidine: dexmedetomidine infusion titrated to effect	Standard of care per treating physician preference
Period Title: Overall Study
STARTED	25	28
COMPLETED	25	28
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Infusion of Dexmedetomidine	Standard of Care	Total
Arm/Group Description	infusion 0.3-0.7 dexmedetomidine Dexmedetomidine: dexmedetomidine infusion titrated to effect	Standard of care per treating physician preference	Total of all reporting groups
Overall Participants	25	28	53
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.00 (10.36)	63.93 (11.55)	63.96 (10.90)
Sex: Female, Male (Count of Participants)
Female	8 32%	7 25%	15 28.3%
Male	17 68%	21 75%	38 71.7%
Region of Enrollment (participants) [Number]
United States	25 100%	28 100%	53 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Infusion of Dexmedetomidine	Standard of Care
Arm/Group Description	infusion 0.3-0.7 dexmedetomidine Dexmedetomidine: dexmedetomidine infusion titrated to effect	Standard of Care Per treating attending physician preference
Measure Participants	25	28
Count of Participants [Participants]	21 84%	14 50%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Infusion of Dexmedetomidine	Standard of Care
Arm/Group Description	infusion 0.3-0.7 dexmedetomidine Dexmedetomidine: dexmedetomidine infusion titrated to effect	Standard of Care Per treating physician preference
Measure Participants	25	28
Median (Inter-Quartile Range) [days]	1	2

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Infusion of Dexmedetomidine	Standard of Care
Arm/Group Description	infusion 0.3-0.7 dexmedetomidine Dexmedetomidine: dexmedetomidine infusion titrated to effect	Standard of Care Per attending physician preference
Measure Participants	25	28
Median (Inter-Quartile Range) [days]	7	7.5

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Infusion of Dexmedetomidine	Standard of Care
Arm/Group Description	infusion 0.3-0.7 dexmedetomidine Dexmedetomidine: dexmedetomidine infusion titrated to effect	Standard of care per attending physician's preference
Measure Participants	25	28
Mostly easy	16 64%	7 25%
Easy to manage 75% of the time	4 16%	2 7.1%
Not easy to manage	5 20%	19 67.9%

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Infusion of Dexmedetomidine	Standard of Care
Arm/Group Description	infusion 0.3-0.7 dexmedetomidine Dexmedetomidine: dexmedetomidine infusion titrated to effect	Standard of Care Per treating physician's preference
Measure Participants	25	28
Yes, died	1 4%	5 17.9%
No, did not die	24 96%	23 82.1%

Adverse Events

Arm/Group Title	Infusion of Dexmedetomidine		Standard of Care
Arm/Group Description	infusion 0.3-0.7 dexmedetomidine Dexmedetomidine: dexmedetomidine infusion titrated to effect		Standard of care per treating physician preference
All Cause Mortality
	Infusion of Dexmedetomidine		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Infusion of Dexmedetomidine		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/28 (0%)
Other (Not Including Serious) Adverse Events
	Infusion of Dexmedetomidine		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/28 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.