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

Mass General Brigham

Status and phase: Completed; Phase 2

Conditions: Agitation; Delirium

Treatments: Drug: Dexmedetomidine; Other: Standard of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT00351299

2005-P-001786, BWH

Details and patient eligibility

About

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

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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53 participants in 2 patient groups

Infusion of dexmedetomidine

Experimental group

Description:

infusion 0.3-0.7 dexmedetomidine

Treatment:

Drug: Dexmedetomidine

Standard of Care

Other group

Description:

Standard of care per treating physician preference

Treatment:

Other: Standard of Care