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Effects of Dexmedetomidine in Patients With Agitated Delirium in Palliative Care
Sponsor: Bruyère Health Research Institute.
Summary
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.
Official title: Effects of Dexmedetomidine in Patients With Agitated Delirium in Palliative Care: an Open-label Phase 1/2 Proof-of-concept, Feasibility, and Dose-finding Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2024-01-30
Completion Date
2026-03-31
Last Updated
2025-04-15
Healthy Volunteers
No
Interventions
Dexmedetomidine Hydrochloride
Dexmedetomidine will be administered by subcutaneous continuous infusion using a Continuous Ambulatory Delivery Device (CADD pump).
Locations (3)
Foothills Medical Centre
Calgary, Alberta, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Bruyère Continuing Care
Ottawa, Ontario, Canada