Recruiting
Phase 1
Phase 2

Dexmedetomidine

Sponsor:

Bruyere Research Institute

Code:

NCT04824144

Conditions

Hyperactive Delirium

Delirium of Mixed Origin

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dexmedetomidine Hydrochloride

Study Details

Brief 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.

Conditions

Hyperactive Delirium

Delirium of Mixed Origin

Study ID

NCT04824144

Start date

Jan 30, 2024

Status verified date

Aug, 2024

Completion date

Mar 31, 2026

Anticipated

Primary completion date

Jan 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dexmedetomidine subcutaneous continuous infusion

Participants will be given a starting low dose of 0.4 mcg/kg/hr, to be titrated up to a medium dose of 0.7 mcg/kg/hr and potentially up to a maximum dose of 1.0 mcg/kg/hr by subcutaneous infusion until the target RASS-PAL level has been achieved.

Interventions

Dexmedetomidine Hydrochloride

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

Primary outcome measure

  • Dosing - Therapeutic Dose [ Time Frame: Enrollment to study withdrawal, hospital discharge, or death, whichever is first ]
  • Dosing - Time [ Time Frame: Enrollment to study withdrawal, hospital discharge, or death, whichever is first ]
  • Number of Participants With Adverse Events - Bradycardia [ Time Frame: Enrollment to study withdrawal, hospital discharge, or death, whichever is first ]
  • Number of Participants With Adverse Events - Hypotension [ Time Frame: Enrollment to study withdrawal, hospital discharge, or death, whichever is first ]
  • Number of Participants With Adverse Events - Skin Tolerability [ Time Frame: Enrollment to study withdrawal, hospital discharge, or death, whichever is first ]
  • Recruitment Rate [ Time Frame: Through study completion, up to 1 year ]
  • Cost [ Time Frame: Through study completion, up to 13 months ]
  • Baseline Agitation [ Time Frame: Baseline ]
  • Baseline Delirium Severity [ Time Frame: Baseline ]
  • Change in Agitation [ Time Frame: Measured at Day 1 - 1 hour post administration, one hour post any dose change, and once daily from Day 1 to intervention completion (up to 13 months) ]
  • Change in Delirium Severity [ Time Frame: Measured every 8 hours from Day 1 to intervention completion (up to 13 months) ]

Central Contacts and Locations

Central contacts

James Downar, MDCM, MSc

6135626262jdownar@toh.ca

Julie Lapenskie, MSc

6135626262jlapenskie@bruyere.org

Locations

Foothills Medical Centre

Recruiting

Calgary, Alberta, Canada, T2N 2T9

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Bruyère Continuing Care

Recruiting

Ottawa, Ontario, Canada, K1N 5C8

More Information

Sponsor

Bruyere Research Institute

Last update posted

Apr 15, 2025

Last verified

Aug, 2024

Keywords

  • Dexmedetomidine
  • Agitation
  • Delirium
  • Palliative
  • End of life

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bruyere Research Institute on 2025-04-15.