RecruitingPhase 1Phase 2NCT04824144

Effects of Dexmedetomidine in Patients With Agitated Delirium in Palliative Care

Effects of Dexmedetomidine in Patients With Agitated Delirium in Palliative Care: an Open-label Phase 1/2 Proof-of-concept, Feasibility, and Dose-finding Clinical Trial


Sponsor

Bruyère Health Research Institute.

Enrollment

50 participants

Start Date

Jan 30, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Dexmedetomidine Hydrochloride for people with delirium of mixed origin and hyperactive delirium. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDexmedetomidine Hydrochloride

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


Locations(3)

Foothills Medical Centre

Calgary, Alberta, Canada

The Ottawa Hospital

Ottawa, Ontario, Canada

Bruyère Continuing Care

Ottawa, Ontario, Canada

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NCT04824144


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