Randomized Controlled Trial of Dexmedetomidine for the Treatment of Intensive Care Unit (ICU) Delirium - Full Text View

Sponsored by:	Brigham and Women's Hospital
Information provided by:	Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT00351299

Purpose

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	Intervention	Phase
Delirium Agitation Sedation	Drug: Dexmedetomidine	Phase II

Drug Information available for: Dexmedetomidine Dexmedetomidine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study
Official Title:	Study of Dexmedetomidine as an Effective Sedative to Treat Acute ICU Delirium

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:

Resolution of delirium as defined

Secondary Outcome Measures:

Decreased length of ventilator support
Decreased length of ICU stay
Decreased need for additional sedatives.
Easier to manage for the nursing staff
Decreased hospital stay
Decreased in-hospital mortality.

Study Start Date:

January 2006

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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,
Trauma <24 hours,
Head injury,
Multiple organ failure,
EF < 30%,
History of hypersensitivity to alpha2 agonist,
History of seizures, MAP<60 mm of Hg,
Dysrhythmias a/with bradycardia (HR <50),
Need for vasopressors,
Acute renal failure with a need for dialysis/CVVH 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00351299

Contacts

Contact: Namrata Patil, MD, MPH		npatil@partners.org
Contact: Gerald Weinhouse, MD		gweinhouse@partners.org

Locations

United States, Massachusetts
Brigham and Women's Hospital	Recruiting
Boston, Massachusetts, United States, 02118
Contact: Namrata Patil, MD, MPH 617-732-8042 npatil@partners.org
Contact: Gerald L Weinhouse, MD
Principal Investigator: Gerald L Weinhouse, MD
Sub-Investigator: Namrata Patil, MD, MPH

Sponsors and Collaborators

Brigham and Women's Hospital

Investigators

Principal Investigator:

Gerald L Weinhouse, MD

Brigham and Women's Hospital

More Information

Study ID Numbers:	2005-P-001786, BWH
Study First Received:	July 10, 2006
Last Updated:	April 23, 2007
ClinicalTrials.gov Identifier:	NCT00351299
Health Authority:	United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:

Delirium
Agitation
Sedation
Dexmedetomidine
Surgical

Study placed in the following topic categories:

Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Neurologic Manifestations
Confusion
Psychomotor Agitation

Dexmedetomidine
Dementia
Dyskinesias
Neurobehavioral Manifestations
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Neurotransmitter Agents
Adrenergic alpha-Agonists
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Nervous System Diseases
Physiological Effects of Drugs
Central Nervous System Depressants
Adrenergic Agonists
Pharmacologic Actions

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Hypnotics and Sedatives
Psychomotor Disorders
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009