Phase 2 N=53 Randomized Double-blind Treatment

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

Delirium · Agitation

Bottom Line

View on ClinicalTrials.gov: NCT00351299 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2017

Primary outcome: Primary: Resolution of Delirium — 21; 14 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Dexmedetomidine (Drug); Standard of Care (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Brigham and Women's Hospital
Primary completion: Oct 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Resolution of Delirium	21; 14	—
SECONDARY Length of Ventilator Support	1; 2	—
SECONDARY Length of Intensive Care Unit (ICU) Stay	7; 7.5	—
SECONDARY Ease of Management for the Nursing Staff	16; 7; 4; 2; 5; 19	—
SECONDARY In-hospital Mortality	1; 5; 24; 23	—

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

Eligibility Criteria

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 (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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00351299). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.