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 groupLocations
3Foothills Medical CentreT2N 2T9, CalgaryAlberta, Canada
Bruyère Continuing CareK1N 5C8, OttawaOntario, Canada
The Ottawa HospitalK1H 8L6, OttawaOntario, Canada
Sponsors and collaborators
Bruyère Health Research Institute.
Lead sponsor
The Ottawa Hospital
Collaborator
Bruyère Continuing Care
Collaborator
Foothills Medical Centre
Collaborator
Source ClinicalTrials.gov