Quetiapine for Delirium Prophylaxis in High-risk Critically Ill Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Incidence of delerium
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Trauma/surgical patients admitted to the trauma/surgical ICU
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Quetiapine (Drug)
结局指标
主要结局
Incidence of delerium
时间窗: One year
ICU length of stay
次要结局
未报告次要终点
研究者
Brian Daley
Professor
University of Tennessee Graduate School of Medicine