Status:
RECRUITING
Effects of Dexmedetomidine in Patients With Agitated Delirium in Palliative Care
Lead Sponsor:
Bruyère Health Research Institute.
Collaborating Sponsors:
The Ottawa Hospital
Bruyère Continuing Care
Conditions:
Hyperactive Delirium
Delirium of Mixed Origin
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 patie...
Detailed Description
Delirium is a common and challenging complication to manage at the end of life. An estimated 75% (range 58-88%) of patients experience delirium during a palliative inpatient admission in the weeks pri...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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)
Key Trial Info
Start Date :
January 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04824144
Start Date
January 30 2024
End Date
March 31 2026
Last Update
April 15 2025
Active Locations (3)
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1
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
2
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
3
Bruyère Continuing Care
Ottawa, Ontario, Canada, K1N 5C8