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

NCT00351299 | Completed Phase 2 Results DMC

• 1 other identifier: 2005-P-001786, BWH
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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

Conditions

Delirium; Agitation

Keywords

Delirium; Agitation; Sedation; Dexmedetomidine; Surgical

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 7 days

Secondary Outcomes (4)

• 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

• 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

• Ease of Management for the Nursing Staff

  Up to initial 48 hours

• 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

Study Arms (2)

Infusion of dexmedetomidine

EXPERIMENTAL

infusion 0.3-0.7 dexmedetomidine

Drug: Dexmedetomidine

Standard of Care

OTHER

Standard of care per treating physician preference

Other: Standard of Care

Interventions

Dexmedetomidine DRUG

dexmedetomidine infusion titrated to effect

Also known as: Precedex

Infusion of dexmedetomidine

Standard of Care OTHER

Standard of care per treating physician preference

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Eligibility for treatment- Development of delirium as defined
• 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)

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Delirium; Psychomotor Agitation

Interventions

Dexmedetomidine; Standard of Care

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Dyskinesias; Psychomotor Disorders; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Dr. Gerald Weinhouse
• Organization: BrighamHospital

gweinhouse@partners.org

617-732-5499

Study Officials

• Gerald L Weinhouse, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: July 10, 2006
• First Posted: July 12, 2006
• Study Start: January 1, 2006
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: June 9, 2017
• Results First Posted: May 9, 2017

Record last verified: 2017-05

Locations

US (1)