Quetiapine for Delirium Prophylaxis in High-risk Critically Ill Patients

Study Overview
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Brief Summary
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Scheduled, low-dose quetiapine is effective in preventing delirium in high-risk critically ill, trauma/surgical patients. Prophylaxis also reduced ventilator duration and ICU length of stay.

Detailed Description
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Objective: To evaluate the efficacy of scheduled quetiapine for delirium prophylaxis in critically ill, trauma/surgical patients identified as high-risk for delirium utilizing a validated prediction model. Design: Prospective, open-label, single-center study. Setting: Trauma/surgical intensive care unit at an academic medical center. Patients: Eighty two adult trauma/surgical patients who were admitted to the intensive care unit and were at high-risk for the development of delirium (PRE-DELIRIC Score ≥50%, past medical history of dementia, past medical history of alcohol misuse, or past medical history of drug abuse). Interventions: Patients were randomized by unit location to receive pharmacologic prophylaxis for delirium (quetiapine 12.5 mg every 12 hours) or no pharmacologic prophylaxis for delirium within forty-eight hours of admission to the intensive care unit. Measurements: The primary end point was the incidence of delirium during admission to the intensive care unit (ICU). Secondary end points included time to onset of delirium, ICU and hospital lengths of stay, ICU and hospital mortality, duration of mechanical ventilation, and adverse events. Delirium was assessed using the confusion assessment method for the intensive care unit.

Official Title
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Quetiapine for Delirium Prophylaxis in High-risk Critically Ill Patients

Conditions
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Psychomotor Agitation

Intervention / Treatment
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* Drug: Quetiapine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Trauma/surgical patients admitted to the trauma/surgical ICU Exclusion Criteria: sustained RASS of -4/-5 during the complete ICU admission presence of a condition preventing delirium assessment anticipated or known ICU length of stay of less than 48 hours taking antipsychotics prior to admission history of schizophrenia, epilepsy, parkinsonism, or levodopa treatment primary neurologic event/injury with GCS ≤ 9 during the first 48 hours of ICU current treatment with a continuous infusion neuromuscular blocking agent pregnancy screened positive for delirium upon admission to the ICU.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Care<br>Standard care for delerium | |
| Active Comparator: Quetiapine<br>Quetiapine therapy was initiated at 12.5 mg twice daily a. After thefirst dose of quetiapine 12.5 mg, the regimen could then be adjusted by the rounding surgeon. If the surgeon felt benefit from receiving a higher dose of quetiapine the dose could then be increased. Quetiapine was discontinued if adverse events (torsades de pointes or other ventricular tachycardias) occurred. All patients receiving at least one dose of quetiapine were included in the final intention-to-treat analyses. All prescribing decisions were left to the discretion of the rounding surgeon and were not mandated as part of the study. | Drug: Quetiapine<br>* escalating dose to prevent delerium.<br>* Other names: Seroquel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of delerium | ICU length of stay | One year |