A single centre pilot randomised controlled trial of enteral Guanfacine vs Quetiapine for agitated delirium in patients in the intensive care unit
Austin Hospital
36 participants
Dec 9, 2024
Interventional
Conditions
Summary
Delirium is one of the most common neurological problems among hospitalized patients, especially in the intensive care unit (ICU). The prevalence of delirium among hospitalized patients ranges from 9.6% to 94.8%. Delirium is a risk factor for increased hospital length of stay (LOS) and decreased chance of home discharge. Patients experiencing agitated delirium often have poorer outcomes. In response, we will perform a single centre pilot randomised controlled trial of enteral guanfacine vs quetiapine for agitated delirium in patients in the intensive care unit. A total of 36 eligible patients will be allocated, on a 1:1 basis to either guanfacine or quetiapine for a period of 7-days while in ICU. Our findings will provide insights into the safety, efficacy and feasibility of guanfacine administration to agitated ICU patients.
Eligibility
Inclusion Criteria6
- Adults aged equal to or older than 18 years
- Admitted to the intensive care unit
- Richmond Agitation Sedation Scale (RASS) score range of +1 to +4 points (agitation)
- Physician has a plan to prescribe antipsychotic agent for treat agitation or delirium
- The treating physician believed that guanfacine or quetiapine are equally appropriate for such treatment
- Likely to remain in the ICU until the day after tomorrow
Exclusion Criteria11
- Admitted with a primary neurologic condition or injury, for example ischemic stroke, intracranial hemorrhage, active seizure
- History of hepatic encephalopathy or end-stage liver disease defined as a Childs-Pugh class B or worse.
- Previous diagnosis of psychiatric disorder or history of substance abuse
- Actively withdrawing from alcohol intoxication and delirium tremens
- Antipsychotic agent uses in the 10 days prior to Intensive care unit admission
- Current treatment with dexmedetomidine or clonidine
- Current treatment with an agent the potential to affect guanfacine or quetiapine concentrations that include cytochrome P450 subtype 3A4 inducer (e.g. phenobarbital, phenytoin, carbamazepine, rifampin) and 3A4 inhibitors (e.g. ketoconazole, voriconazole, clarithromycin)
- Known allergy to guanfacine or quetiapine
- Any contraindication to guanfacine or quetiapine includes borderline unsupported blood pressure defined by systolic blood pressure less than 90 mmHg or diastolic blood pressure less than 40 mmHg, heart rate less than 50 beats per minute, and baseline QTc interval greater than 500 milliseconds.
- Renal impairment which defined by creatinine clearance less than 30 ml/min, calculate by Cockcroft-Gault equation
- Suspected or confirmed pregnancy at time of assessment of eligibility
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Interventions
Patients allocated to the intervention group will receive guanfacine for the treatment of agitated delirium. Guanfacine hydrochloride will be a single 2 mg dose given once a day via the oral route at the discretion of the treating ICU doctor for a maximum of 7 days while the patient is in ICU. From enrolment until day 8, treating ICU doctors will be permitted to use medication other than quetiapine for the treatment of delirium/agitation should it become necessary. On day 8 and onwards, the choice of anti-psychotic drug/agent will be at the discretion of the treating ICU doctors. All other aspects of care will conform to usual ICU practice. Blood pressure, heart rate will be monitored continuously and QTc interval will be monitored as per usual routine care in intensive care unit.
Locations(1)
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ACTRN12624001075572