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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 1 year
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Baseline Agitation
Baseline Delirium Severity
Change in Agitation
+8 more
Secondary outcome measures
Baseline Opioid Use
Baseline Pain
Change in Opioid Use From Baseline
+1 more

Side effects data

From 2015 Phase 4 trial • 60 Patients • NCT03078946
3%
Delirium
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dexmedetomidine Group (N=30)
Morphine With Midazolam (N=30)

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
~940

Find a Location

Who is running the clinical trial?

Bruyère Continuing CareUNKNOWN
Ottawa Hospital Research InstituteLead Sponsor
561 Previous Clinical Trials
2,785,641 Total Patients Enrolled
2 Trials studying Delirium
340 Patients Enrolled for Delirium
Elisabeth Bruyere HospitalUNKNOWN

Media Library

Dexmedetomidine Hydrochloride (Alpha-2 Adrenergic Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04824144 — Phase 1 & 2
Delirium Research Study Groups: Dexmedetomidine subcutaneous continuous infusion
Delirium Clinical Trial 2023: Dexmedetomidine Hydrochloride Highlights & Side Effects. Trial Name: NCT04824144 — Phase 1 & 2
Dexmedetomidine Hydrochloride (Alpha-2 Adrenergic Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04824144 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical indications are typically addressed with Dexmedetomidine subcutaneous continuous infusion?

"Dexmedetomidine subcutaneous infusion is a widely used medication for the treatment of various conditions such as ventilations, mechanical, cyclic vomiting syndrome and intubation."

Answered by AI

What is the current enrollment for this clinical trial?

"Correct. The information hosted on clinicaltrials.gov illustrates that this medical trial, which was first advertised on June 13th 2022 is still recruiting for participants. Specifically, 50 individuals need to be enrolled at 4 distinct sites."

Answered by AI

Is participation in this clinical experiment still available?

"According to the records on clinicaltrials.gov, this medical investigation is still recruiting participants. This experiment was first publicized on June 13th 2022 and the most recent update was made on December 16th of that same year."

Answered by AI

Has Dexmedetomidine subcutaneous continuous infusion been explored in other investigations?

"Dexmedetomidine subcutaneous continuous infusion was first studied in 2011 at the Meilahti Hospital, located within Helsinki University Central Hospital. Since then, 575 trials have been completed and 109 are currently underway with a considerable concentration of them found near Kingston, Ontario."

Answered by AI

What results is this medical research attempting to achieve?

"This clinical trial seeks to measure Baseline over a set period of time. Secondary objectives encompass evaluating the participant's Baseline Opioid Use, as quantified by their MEDD and breakthrough dose frequency; Change in Pain From Baseline via CPOT scores (with higher numbers indicating increased pain levels); and Changes in Opioid Use From Baseline, also gauged usingMEDD and breakthrough dose occurrences."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Effects of Dexmedetomidine in Patients With Agitated Delirium in Palliative Care
James Downar 2023. "Effects of Dexmedetomidine in Patients With Agitated Delirium in Palliative Care". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04824144.
~29 spots leftby Nov 2024
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