MedTrace Logo

Effects of Dexmedetomidine in Patients With Agitated Delirium in Palliative Care

NCT04824144 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-04-15

No results posted yet for this study

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

Interventions

DRUG

Dexmedetomidine Hydrochloride

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

Sponsors & Collaborators

  • The Ottawa Hospital

    collaborator OTHER

  • Bruyère Continuing Care

    collaborator UNKNOWN

  • Foothills Medical Centre

    collaborator OTHER

  • Bruyère Health Research Institute.

    lead OTHER

Principal Investigators

  • James Downar, MDCM, MSc · Bruyère Health Research Institute.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-30
Primary Completion
2026-01-31
Completion
2026-03-31

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04824144 on ClinicalTrials.gov