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

NCT ID: NCT00351299

Last Updated: 2017-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2012-10-31

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.

Conditions

Delirium; Agitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Infusion of dexmedetomidine

infusion 0.3-0.7 dexmedetomidine

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

dexmedetomidine infusion titrated to effect

Standard of Care

Standard of care per treating physician preference

Group Type: OTHER

Standard of Care

Intervention Type: OTHER

Standard of care per treating physician preference

Interventions

Dexmedetomidine

dexmedetomidine infusion titrated to effect

Intervention Type: DRUG

Standard of Care

Standard of care per treating physician preference

Intervention Type: OTHER

Other Intervention Names

Precedex

Eligibility Criteria

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Gerald L. Weinhouse

Staff Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gerald L Weinhouse, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2005-P-001786, BWH

Identifier Type: -

Identifier Source: org_study_id