BridgeMD
New treatment option for Hyperactive Delirium
Official title Effects of Dexmedetomidine in Patients With Agitated Delirium in Palliative Care
ClinicalTrials.gov ID: NCT04824144
What this study is testing
What is Dexmedetomidine Hydrochloride?
Dexmedetomidine Hydrochloride is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for hyperactive delirium.
Also referred to as Dexmedetomidine, Precedex.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 6 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult patients (≥18 years)
- Admitted to a participating inpatient palliative care unit
- Meeting one of the following criteria:
- Agitated delirium: (i) Richmond Agitation-Sedation Scale for palliative care patients (RASS-PAL) score of +2 or greater and (ii) Confusion Assessment...
- Previous history of delirium (in the last 6 months)
You likely can't join if
- Hemodynamic instability (systolic blood pressure \<80mmHg)
- Bradyarrhythmia (heart rate \< 60) at baseline
- Patients on verapamil, diltiazem, or beta-blocker (patients are eligible if these medications are stopped prior to receiving dexmedetomidine)
See the full eligibility criteria
- Adult patients (≥18 years)
- Admitted to a participating inpatient palliative care unit
- Meeting one of the following criteria:
- Agitated delirium: (i) Richmond Agitation-Sedation Scale for palliative care patients (RASS-PAL) score of +2 or greater and (ii) Confusion Assessment Method (CAM) positive status and (iii) Without a known potentially...
- Previous history of delirium (in the last 6 months)
- Patient is within the last two weeks of life and is expected to die during this admission (MRP judgement)
- Hemodynamic instability (systolic blood pressure \<80mmHg)
- Bradyarrhythmia (heart rate \< 60) at baseline
- Patients on verapamil, diltiazem, or beta-blocker (patients are eligible if these medications are stopped prior to receiving dexmedetomidine)
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
- Ottawa, Ontario, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada; Ottawa, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.