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Effects of Dexmedetomidine in Patients With Agitated Delirium in Palliative Care

ConditionsHyperactive DeliriumDelirium of Mixed Origin
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBruyère Health Research Institute.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients (≥18 years)

Admitted to a participating inpatient palliative care unit

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 reversible cause (e.g. hypercalcemia, specific medication infection, etc.), or in whom the patient/Substitute Decision Maker (SDM) has requested not to treat the cause.

Previous history of delirium (in the last 6 months)

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • Dexmedetomidine Hydrochloride

    Drug

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

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Dexmedetomidine subcutaneous continuous infusionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dosing - Therapeutic Dose

Dose at which the target Richmond Agitation Sedation Scale-Palliative (RASS-PAL) score of -1 ("drowsy"), 0 ("alert and calm"), or +1 ("restless") is achieved. The RASS-PAL is a 10-point scale with scores ranging from -5 (not rousable) to +4 (combative).

Time frame
Enrollment to study withdrawal, hospital discharge, or death, whichever is first
2

Dosing - Time

Time (in hours) at which the target Richmond Agitation Sedation Scale-Palliative (RASS-PAL) score of -1 ("drowsy"), 0 ("alert and calm"), or +1 ("restless") is achieved. The RASS-PAL is a 10-point scale with scores ranging from -5 (not rousable) to +4 (combative).

Time frame
Enrollment to study withdrawal, hospital discharge, or death, whichever is first
3

Number of Participants With Adverse Events - Bradycardia

Proportion of participants with Bradycardia (two consecutive readings of heart rate (HR)\<40 beats/minute)

Time frame
Enrollment to study withdrawal, hospital discharge, or death, whichever is first
4

Number of Participants With Adverse Events - Hypotension

Proportion of participants with Hypotension (systolic blood pressure(SBP) \< 70 mmHg or 40% drop from baseline with lightheadedness or loss of consciousness.

Time frame
Enrollment to study withdrawal, hospital discharge, or death, whichever is first

Secondary outcomes

1

Baseline Pain

Measured using the Critical Care Pain Observation Tool (CPOT) (higher score indicates worse pain).

Time frame
Baseline
2

Change in Pain From Baseline

Measured using the Critical Care Pain Observation Tool (CPOT) (higher score indicates worse pain).

Time frame
Measured once daily from Day 1 to intervention completion (up to 13 months)
3

Baseline Opioid Use

Measured using the oral Morphine-Equivalent Daily Dose (MEDD) and frequency of breakthrough dose for each participant

Time frame
Measured at Baseline
4

Change in Opioid Use From Baseline

Measured using the oral Morphine-Equivalent Daily Dose (MEDD) and frequency of breakthrough dose for each participant

Time frame
Measured once daily from Day 1 to intervention completion (up to 13 months)

Other outcomes

Sponsors and contacts

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Bruyère Health Research Institute.

Lead sponsor

The Ottawa Hospital

Collaborator

Bruyère Continuing Care

Collaborator

Foothills Medical Centre

Collaborator

Source ClinicalTrials.gov
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