Effects of Dexmedetomidine in Patients With Agitated Delirium in Palliative Care
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBruyère Health Research Institute.
About this trial
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 criteria
Qualifiers
Adult patients (≥18 years)
Admitted to a participating inpatient palliative care unit
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)
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Dexmedetomidine Hydrochloride
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
Bruyère Health Research Institute.
Lead sponsor
The Ottawa Hospital
Collaborator
Bruyère Continuing Care
Collaborator
Foothills Medical Centre
Collaborator
Source ClinicalTrials.gov