RecruitingPhase 2ACTRN12624001075572

A single centre pilot randomised controlled trial of enteral Guanfacine vs Quetiapine for agitated delirium in patients in the intensive care unit


Sponsor

Austin Hospital

Enrollment

36 participants

Start Date

Dec 9, 2024

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Delirium is a sudden state of confusion that is very common in intensive care units (ICUs). When patients become agitated alongside their delirium, it can be distressing and dangerous, and doctors often prescribe medications to calm them down. This trial is comparing two such medications — guanfacine and quetiapine — to see which one is safer and more effective for agitated ICU patients. This is a small pilot study involving 36 patients at a single hospital. Eligible patients will be randomly assigned to receive either guanfacine or quetiapine for up to 7 days while they remain in the ICU. Researchers will closely track how patients respond, what side effects occur, and whether one drug works better than the other. You may be eligible if you are 18 or older, currently in an ICU, showing signs of agitation, and your doctor believes either medication would be appropriate. People with certain liver conditions, neurological injuries, psychiatric disorders, heart problems, or who are pregnant are not eligible. The results of this study will help guide future treatment of this challenging condition.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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)

Austin Health - Austin Hospital - Heidelberg

VIC, Australia

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ACTRN12624001075572