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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00351299
Other study ID # 2005-P-001786, BWH
Secondary ID
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


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.
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