Quetiapine for Delirium Prophylaxis in High-risk Critically Ill Patients
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|ClinicalTrials.gov Identifier: NCT02612948|
Recruitment Status : Completed
First Posted : November 24, 2015
Last Update Posted : November 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Psychomotor Agitation||Drug: Quetiapine||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||82 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Quetiapine for Delirium Prophylaxis in High-risk Critically Ill Patients|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
No Intervention: Standard Care
Standard care for delerium
Active Comparator: Quetiapine
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.
escalating dose to prevent delerium.
Other Name: Seroquel
- Incidence of delerium [ Time Frame: One year ]ICU length of stay
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02612948
|United States, Tennessee|
|University of Tennessee Medical Center|
|Knoxville, Tennessee, United States, 37922|
|Principal Investigator:||Brian Daley||University General Surgeons, P.C.|