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Alpha-2 Adrenergic Agonist

Dexmedetomidine for Delirium

Phase 1 & 2

Recruiting

Led By James Downar, MDCM, MSc

Research Sponsored by Ottawa Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult patients (≥18 years) admitted to a participating inpatient palliative care unit

Be older than 18 years old

Must not have

Hemodynamic instability (systolic blood pressure <80mmHg)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trialtests how safe and effective a drug is for reducing agitation and delirium in 50 patients near the end of life.

Who is the study for?

This trial is for adults with agitated delirium in palliative care, who've had delirium recently or are in their last two weeks of life. They must have a specific level of agitation and confusion without reversible causes, or choose not to treat such causes. It's not for those with very low blood pressure, slow heart rate, or taking certain heart medications unless stopped before the trial.

What is being tested?

The study tests dexmedetomidine's ability to manage agitated delirium at the end-of-life stage. Fifty patients will receive varying doses subcutaneously in a non-monitored setting. The focus is on finding the right dose and seeing how well it works by looking at recruitment rates, costs, safety through adverse events tracking, and its effect on agitation and severity of delirium.

What are the potential side effects?

Potential side effects may include changes in blood pressure or heart rate due to dexmedetomidine’s sedative properties. Since this drug affects brain activity related to alertness and can influence cardiovascular function, monitoring these parameters will be part of assessing safety.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 or older and admitted to a palliative care unit.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My blood pressure is stable and not below 80mmHg.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Baseline Agitation

Baseline Delirium Severity

Change in Agitation

+8 more

Secondary study objectives

Baseline Opioid Use

Baseline Pain

Change in Opioid Use From Baseline

+1 more

Side effects data

From 2015 Phase 4 trial • 60 Patients • NCT03078946

Delirium

100%

80%

60%

40%

20%

Study treatment Arm

Dexmedetomidine Group (N=30)

Morphine With Midazolam (N=30)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dexmedetomidine subcutaneous continuous infusionExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexmedetomidine Hydrochloride

2013

Completed Phase 4

~1000

0 / 2Eligibility criteria met