Haloperidol Prophylaxis in Cardiac Surgery for Patients at Risk for Delirium: A Randomized Placebo-Controlled Pilot Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Feasibility of conducting a trial utilizing low dose Haloperidol use in patients post cardiac surgery
研究概览
简要总结
Will the use of prophylactic Haloperidol for patients undergoing open heart surgery reduce the incidence, duration, and severity of post cardiotomy delirium?
详细描述
Pilot study for feasibility and safety, n = 40, haloperidol 1mg vs. placebo BID administered night before and day of surgery, then continued for total 72hrs post-op, if delirium occurs study drug is stopped and usual standard of care implemented by MRP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Greater than or equal to 70 years of age, undergoing a median sternotomy OR 60-69yrs of age with one or more of the risk factors:
- •TIA/Stroke;
- •Euroscore greater than or equal to 5;
- •abnormal clock draw.
排除标准
- •Parkinsonism,
- •on any antipsychotic medications pre-op,
- •active delirium,
- •emergent surgery,
- •Haloperidol allergy,
- •schizophrenia,
- •prolonged QTc.
研究组 & 干预措施
Haloperidol
Haloperidol 1mg the night before and 1mg the morning of surgery; OR Haloperidol 2mg the morning of surgery
干预措施: Haloperidol (Drug)
Placebo
1 dose the night before and 1 dose the morning of surgery; OR 2 doses the morning of surgery
干预措施: Placebo (Drug)
结局指标
主要结局
Feasibility of conducting a trial utilizing low dose Haloperidol use in patients post cardiac surgery
时间窗: Participants will be followed for the duration of their hospital stay to a maximum of 30 days.
If a participant does not develop delirium post operatively, then the confusion assessment method (CAM)will be monitored for 24 hours after the study medication ends. Patients will be followed up until seven days or until discharge if no delirium occurs, or if delirium is detected, up to 30 days or until discharge
Safety monitoring of low dose Haloperidol use in patients post cardiac surgery
时间窗: Participants will be followed for the duration of their hospital stay to a maximum of 30 days
If a participant does not develop delirium post operatively, then the confusion assessment method (CAM)will be monitored for 24 hours after the study medication ends. Patients will be followed up until seven days or until discharge if no delirium occurs, or if delirium is detected, up to 30 days or until discharge
次要结局
- Total length of stay (LOS), with breakdown for intensive care unit (ICU) days and ward days(Participants will be followed for the duration of their hospital stay to a maximum of 30 days)
- The incidence of delirium(Participants will be followed for the duration of their hospital stay to a maximum of 30 days)
- Delirium severity(Participants will be followed for the duration of their hospital stay to a maximum of 30 days)
- Duration of delirium(Participants will be followed for the duration of their hospital stay to a maximum of 30 days)
研究者
Andre Lamy
Dr Andre Lamy, MD, FRCSC, MHSc, Cardiac Surgeon
McMaster University