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Effects of Dexmedetomidine in Patients With Agitated Delirium in Palliative Care

Hyperactive Delirium | Delirium of Mixed Origin

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.

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Conditions de participation

  • Sexe:

    ALL

  • Âges admissibles:

    18 and up

Critères de participation

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)

Lieu de l'étude

Bruyère Continuing Care
Bruyère Continuing Care
Ottawa, Ontario
Canada

Contactez l'équipe d'étude

Primary Contact

Peter Lawlor, MD

The Ottawa Hospital
The Ottawa Hospital
Ottawa, Ontario
Canada

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Primary Contact

Henrique Parsons, MD

Foothills Medical Centre
Foothills Medical Centre
Calgary, Alberta
Canada

Contactez l'équipe d'étude

Primary Contact

Jennifer Hughes, MD

Étude parrainée par
Bruyere Research Institute
Participants recherchés
Plus d'informations
ID de l'étude: NCT04824144