Effects of Dexmedetomidine in Patients With Agitated Delirium in Palliative Care
Recruiting now · Phase 1/Phase 2
Conditions studied: Hyperactive Delirium, Delirium of Mixed Origin
In brief
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.
Key facts
- Study ID
- NCT04824144
- Run by
- Bruyère Health Research Institute.
- People needed
- 50
- Starts
- 2024-01-30
- Expected to finish
- 2026-03-31
- Last updated by the study team
- 2025-04-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- Hemodynamic instability (systolic blood pressure <80mmHg)
- Bradyarrhythmia (heart rate < 60) at baseline
- Patients on verapamil, diltiazem, or beta-blocker (patients are eligible if these medications are stopped prior to receiving dexmedetomidine)
Where it is running
- Foothills Medical Centre — Calgary, Alberta, Canada (enrolling)
- The Ottawa Hospital — Ottawa, Ontario, Canada (enrolling)
- Bruyère Continuing Care — Ottawa, Ontario, Canada (enrolling)
Full record on ClinicalTrials.gov
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