Overview

This trial is active, not recruiting.

Conditions delirium, agitation, sedation
Treatment dexmedetomidine
Phase phase 2
Sponsor Brigham and Women's Hospital
Start date January 2006
End date February 2011
Trial size 130 participants
Trial identifier NCT00351299, 2005-P-001786, BWH

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Resolution of delirium as defined
time frame:

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title Study of Dexmedetomidine as an Effective Sedative to Treat Acute ICU Delirium
Principal investigator Gerald L Weinhouse, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2010.
Information provided to ClinicalTrials.gov by Brigham and Women's Hospital.