ACTRN12624001075572
Not yet recruiting
Phase 2
A single centre pilot randomised controlled trial of enteral Guanfacine vs Quetiapine for agitated delirium in patients in the intensive care unit
Austin Hospital0 sites36 target enrollmentSeptember 5, 2024
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Austin Hospital
- Enrollment
- 36
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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