Using dexmedetomidine to manage agitated delirium in palliative care patients

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

This study is testing if a medication called dexmedetomidine can help calm down patients with agitated delirium in palliative care to make them more comfortable at the end of life.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Bruyère Health Research Institute. (Academic / other)
• Locations: 3 sites (Calgary, Alberta and 2 other locations)
• Trial ID: NCT04824144 on ClinicalTrials.gov

What this trial studies

This multi-centre phase I/II open-label, single-arm study aims to assess the feasibility, optimal dosing, and preliminary efficacy of dexmedetomidine for treating agitated delirium in patients nearing the end of life. Fifty adult patients admitted to palliative care units will receive subcutaneous dexmedetomidine, starting at 0.4 mcg/kg/hour and titrated up to 1.0 mcg/kg/hour. The study will evaluate recruitment rates, safety through adverse event monitoring, and preliminary efficacy by measuring agitation and delirium severity. The focus is on improving patient comfort and communication with loved ones during critical end-of-life moments.

Who should consider this trial

Good fit: Ideal candidates include adult patients admitted to palliative care units who exhibit signs of agitated delirium or have a history of delirium within the last six months.

Not a fit: Patients with hemodynamic instability or those on specific heart medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce agitation and distress in patients with agitated delirium, enhancing their quality of life in their final days.

How similar studies have performed: While studies on dexmedetomidine have been conducted, this specific application in palliative care for agitated delirium is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Adult patients (≥18 years)
2. Admitted to a participating inpatient palliative care unit
3. Meeting one of the following criteria:

   1. 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.
   2. Previous history of delirium (in the last 6 months)
   3. Patient is within the last two weeks of life and is expected to die during this admission (MRP judgement)

Exclusion Criteria:

1. Hemodynamic instability (systolic blood pressure \<80mmHg)
2. Bradyarrhythmia (heart rate \< 60) at baseline
3. Patients on verapamil, diltiazem, or beta-blocker (patients are eligible if these medications are stopped prior to receiving dexmedetomidine)

Where this trial is running

Calgary, Alberta and 2 other locations

• Foothills Medical Centre — Calgary, Alberta, Canada (Recruiting)
• The Ottawa Hospital — Ottawa, Ontario, Canada (Recruiting)
• Bruyère Continuing Care — Ottawa, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: James Downar, MDCM, MSc — Bruyère Health Research Institute.
• Study coordinator: James Downar, MDCM, MSc

Conditions Hyperactive Delirium; Delirium of Mixed Origin; Dexmedetomidine; Agitation; Delirium; Palliative; End of life