Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT04824144

Effects of Dexmedetomidine in Patients With Agitated Delirium in Palliative Care

Led by Bruyère Health Research Institute. · Updated on 2025-04-15

50

Participants Needed

3

Research Sites

113 weeks

Total Duration

On this page

Sponsors

B

Bruyère Health Research Institute.

Lead Sponsor

T

The Ottawa Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Effects of Dexmedetomidine in Patients With Agitated Delirium in Palliative Care

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients aged 18 years or older
  • Admitted to a participating inpatient palliative care unit
  • Have agitated delirium with a Richmond Agitation-Sedation Scale for palliative care patients (RASS-PAL) score of +2 or greater and positive Confusion Assessment Method (CAM) status, without a known reversible cause or with a decision not to treat the cause
  • Or have a previous history of delirium in the last 6 months
  • Or are within the last two weeks of life and expected to die during this admission as judged by the medical responsible practitioner
Not Eligible

You will not qualify if you...

  • Hemodynamic instability with systolic blood pressure less than 80 mmHg
  • Bradyarrhythmia with heart rate less than 60 beats per minute at baseline
  • Current use of verapamil, diltiazem, or beta-blocker medications unless stopped before receiving dexmedetomidine

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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2
3
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Trial Site Locations

Total: 3 locations

1

Foothills Medical Centre

Calgary, Alberta, Canada, T2N 2T9

Actively Recruiting

2

The Ottawa Hospital

Ottawa, Ontario, Canada, K1H 8L6

Actively Recruiting

3

Bruyère Continuing Care

Ottawa, Ontario, Canada, K1N 5C8

Actively Recruiting

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Research Team

J

James Downar, MDCM, MSc

CONTACT

J

Julie Lapenskie, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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