Dexmedetomidine Sublingual Film for the Management of Agitation in Delirium: Safety and Preliminary Efficacy
Delirium
About this trial
This is an interventional treatment trial for Delirium focused on measuring agitation, delirium, dexmedetomidine
Eligibility Criteria
Inclusion Criteria:
- Adults hospitalized on a medical or surgical intensive care unit at MGH
- Diagnosis of delirium, assessed according to DSM-5 criteria (DSM-5)
- Body mass index (BMI) between 18 and 30 kg/m2, inclusive, at screening
- Weight at least 60 kg (132 pounds), at screening
- In the opinion of the study and clinical teams, sufficiently physically healthy to receive dexmedetomidine sublingual film
Exclusion Criteria:
Per medical record or team report, diagnoses of:
- Dementia
- Significant traumatic brain injury
- History of stroke, with persistent neurologic deficits
Presence of any of the following cardiovascular comorbidities
- Sick sinus syndrome
- A resting heart rate of < 55 beats per minutes or systolic blood pressure (BP) <100 mmHg or >160 mmHg or diastolic BP <70 mmHg or ˃ 95 mmHg at enrollment and prior to dosing.
- Evidence of cardiac ischemia on a 12-lead electrocardiogram (ECG)
- Corrected QT interval of > 450 msec
- Presence of a permanent pacemaker device
Per medical record (notes, current medications, flowsheets):
- Second degree (or greater) Atrioventricular (AV) block without a pacemaker
- Known allergy or adverse reaction to dexmedetomidine
- Current use of dexmedetomidine
- Inability to take sublingual dexmedetomidine due to severe agitation, neurological impairment, nil per os (NPO) status, or other cause.
- Hepatic impairment (liver function tests > 3 times the upper limit of normal)
- Severe renal impairment (glomerular filtration rate (GFR) < 30 ml/min or on dialysis)
- Weight < 60 kg
- Pregnancy (in women; tested with serum or urine human chorionic gonadotropin [hCG])
- Non-fluency in English
- Prior enrollment in the study, with receipt of study medication, during the current or a previous hospitalization
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
20 mcg
60 mcg
Participants randomized to the 20mcg group will receive 20mcg of dexmedetomidine sublingual film every 30 minutes, if they continue to have agitation and do not meet any cardiovascular stopping criteria. The maximum dosing for this arm is 80mcg.
Participants randomized to the 60mcg group will receive 60mcg of dexmedetomidine sublingual film every 30 minutes, if they continue to have agitation and do not meet any cardiovascular stopping criteria. The maximum dosing for this arm is 240mcg.