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

Delirium Clinical Trial

Official title:

Study of Dexmedetomidine as an Effective Sedative to Treat Acute ICU Delirium

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00351299
• Other study ID #: 2005-P-001786, BWH
• Status: Active, not recruiting
• Phase: Phase 2
• First received: July 10, 2006
• Last updated: May 3, 2010
• Start date: January 2006
• Est. completion date: September 2011

Study information

• Verified date: May 2010
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. completion date: September 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Agitation
• Delirium
• Sedation

Intervention

Drug:
• Dexmedetomidine

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution of delirium as defined
Secondary	Decreased length of ventilator support
Secondary	Decreased length of ICU stay
Secondary	Decreased need for additional sedatives.
Secondary	Easier to manage for the nursing staff
Secondary	Decreased hospital stay
Secondary	Decreased in-hospital mortality.