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RecruitingPhase 1Phase 2NCT04824144

Effects of Dexmedetomidine in Patients With Agitated Delirium in Palliative Care

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

Sponsor

Bruyère Health Research Institute.

Enrollment

50 participants

Start Date

Jan 30, 2024

Study Type

INTERVENTIONAL

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 (0.4 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.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria3

  • 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)

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Interventions

DRUGDexmedetomidine Hydrochloride

Dexmedetomidine will be administered by subcutaneous continuous infusion using a Continuous Ambulatory Delivery Device (CADD pump).

Locations(3)

Foothills Medical Centre

Calgary, Alberta, Canada

The Ottawa Hospital

Ottawa, Ontario, Canada

Bruyère Continuing Care

Ottawa, Ontario, Canada

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NCT04824144