A Phase 4 interventional study of Quetiapine in Psychomotor Agitation, sponsored by University of Tennessee Graduate School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-11-24.
Sponsored by University of Tennessee Graduate School of Medicine · Phase 4, Interventional, and Treatment
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.
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.
1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.
This study's enrollment of 82 is below the median of 120 across 599 interventional studies indexed under Delirium.
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Standard care for delerium
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
escalating dose to prevent delerium.
Also known as: Seroquel
Incidence of delerium
ICU length of stay
Time frame: One year
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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University of Tennessee Graduate School of Medicine