The goal of this multi-centre phase I/II open-label, single-arm study is to determine the feasibility, optimal dose, and preliminary efficacy of dexmedetomidine to manage agitated delirium among patients near the end of life followed by a palliative care provider in a non-monitored setting. Fifty patients will receive dexmedetomidine (0.4 mcg/kg/hour, titrated up to 1.0 mcg/kg/hour) subcutaneously. Feasibility (recruitment rate, cost), safety (rate of adverse events), dosing, and preliminary efficacy (agitation, delirium severity) will be measured.
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Dosing - Therapeutic Dose
Timeframe: Enrollment to study withdrawal, hospital discharge, or death, whichever is first
Dosing - Time
Timeframe: Enrollment to study withdrawal, hospital discharge, or death, whichever is first
Number of Participants With Adverse Events - Bradycardia
Timeframe: Enrollment to study withdrawal, hospital discharge, or death, whichever is first
Number of Participants With Adverse Events - Hypotension
Timeframe: Enrollment to study withdrawal, hospital discharge, or death, whichever is first
Number of Participants With Adverse Events - Skin Tolerability
Timeframe: Enrollment to study withdrawal, hospital discharge, or death, whichever is first
Recruitment Rate
Timeframe: Through study completion, up to 1 year
Cost
Timeframe: Through study completion, up to 13 months
Baseline Agitation
Timeframe: Baseline
Baseline Delirium Severity
Timeframe: Baseline
Change in Agitation
Timeframe: Measured at Day 1 - 1 hour post administration, one hour post any dose change, and once daily from Day 1 to intervention completion (up to 13 months)
Change in Delirium Severity
Timeframe: Measured every 8 hours from Day 1 to intervention completion (up to 13 months)