Brigham and Women's Hospital
Boston, Massachusetts, 02118, United States
NCT Number: NCT00351299
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
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Boston, Massachusetts, 02118, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
dexmedetomidine infusion titrated to effect
Other names: Precedex
Standard of care per treating physician preference
Time frame: Up to 7 days
Resolution of delirium as defined by 2 consecutive negative CAM-ICU assessments.
The Confusion Assessment Method for the ICU (CAM-ICU). The CAM-ICU assesses the four features of delirium: feature 1 is an acute change in mental status or a fluctuating mental status, feature 2 is inattention, feature 3 is altered level of consciousness, and feature 4 is disorganized thinking.
Time frame: Patients will remain in the study for up to 7 days after development of delirium or discharge from ICU whichever is earlier, up to study end
Number of days on mechanical ventilation
Time frame: Patients will remain in the study for up to 7 days after development of delirium or discharge from ICU whichever is earlier, up to study end
Number of days intensive care unit (ICU) stay
Time frame: Up to initial 48 hours
Subjective measure rating 3 categories for ease of management:
Time frame: Patients will remain in the study for up to 7 days after development of delirium or discharge from ICU whichever is earlier, up to study end
Did patient die while in the hospital? (Yes/No)
Brigham and Women's Hospital
Other
Study of Dexmedetomidine as an Effective Sedative to Treat Acute ICU Delirium
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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