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
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.
• Adult patients (≥18 years)
• Admitted to a participating inpatient palliative care unit
• Meeting one of the following criteria:
‣ Agitated delirium: (i) Richmond Agitation-Sedation Scale for palliative care patients (RASS-PAL) score of +2 or greater and (ii) Confusion Assessment Method (CAM) positive status and (iii) Without a known potentially reversible cause (e.g. hypercalcemia, specific medication infection, etc.), or in whom the patient/Substitute Decision Maker (SDM) has requested not to treat the cause.
⁃ Previous history of delirium (in the last 6 months)
⁃ Patient is within the last two weeks of life and is expected to die during this admission (MRP judgement)