NCT04824144 · Phase 1 · RECRUITING
Effects of Dexmedetomidine in Patients With Agitated Delirium in Palliative Care
This trial is testing dexmedetomidine, a sedative drug, to manage severe agitated delirium in patients near the end of life receiving palliative care. Researchers want to find the right dose, confirm it is practical to give subcutaneously outside a monitored hospital setting, and get an early read on whether it works. This is a Phase 1/2 trial, meaning it is focused on safety and dosing, not yet a proven or approved approach.
Eligibility criteria
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)
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-04-15