Effects of Dexmedetomidine in Patients With Agitated Delirium in Palliative Care

• Status: Not yet recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

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 patients near the end of life followed by a palliative care provider in a non-monitored setting. Fifty patients will receive dexmedetomidine (0.2 mcg/kg/hour, titrated up to 0.7 mcg/kg/hour) subcutaneously. Feasibility (recruitment rate, cost), safety (rate of adverse events), dosing, and preliminary efficacy (agitation, delirium severity) will be measured.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bruyere Research Institute; Ottawa Hospital Research Institute
• Collaborators: Bruyere Research Institute; Elisabeth Bruyere Hospital; Foothills Medical Centre; Kingston Health Sciences Centre; Princess Margaret Hospital, Canada; Providence Care Hospital; Providence Hospital; The Ottawa Hospital
• Treatments: Dexmedetomidine

Criteria

Inclusion Criteria:

1. Adult patients (≥18 years)

2. Admitted to a participating inpatient palliative care unit

3. Agitated delirium: (a) Richmond Agitation-Sedation Scale for palliative care patients (RASS-PAL) score of +2 or greater and (b) Confusion Assessment Method (CAM) positive status and (c) 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.

Exclusion Criteria:

1. Hemodynamic instability (systolic blood pressure <80mmHg)

2. Bradyarrhythmia (heart rate < 60) at baseline