Preemptive Pharmacogenetic- Guided Metoprolol Management for Postoperative Atrial Fibrillation in Cardiac Surgery: The PREEMPTIVE- Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 2
- 主要终点
- Incidence of post-operative atrial fibrillation
研究概览
简要总结
Metoprolol is frequently administered to cardiac surgery patients to reduce the incidence of postoperative atrial fibrillation (PoAF). Metoprolol is metabolized by the enzyme CYP2D6, which is known to have many mutations that could influence a patient's ability to metabolize the drug. In this prospective clinical trial, the investigators will determine the genotype of CYP2D6 for patients undergoing cardiac surgery, provide an altered dosing recommendation for metoprolol, then report the relative effectiveness in managing PoAF for each pharmacogenetic- guided dosing category. The investigators will also explore the effects of personalized metoprolol dosing recommendations on outcomes in hospital length of stay, cost, and provider participation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 18 years
- •Scheduled for surgical procedure (coronary artery bypass graft and/or valve repair/replacement) at Vanderbilt University Medical Center
排除标准
- •History of allergic reactions or contraindications to beta-blockers
- •Patients with persistent atrial fibrillation
结局指标
主要结局
Incidence of post-operative atrial fibrillation
时间窗: From the end of anesthesia up to hospital discharge; usually 3-4 days
Incidence of post-operative atrial fibrillation measured with post-operative electrocardiogram or rhythm strip, or at least two of the following: documentation in the progress notes, nursing notes, discharge summary, and change in medication.
次要结局
- Proportion of clinical decision support tool recommendations that were acknowledged but ignored by the provider.(From end of anesthesia to hospital discharge; usually 3-4 days)
- Overall cost of treatment(From end of surgery to hospital discharge; usually 3-4 days)
- Cost of interventions to control or treat post-operative atrial fibrillation(From end of anesthesia to hospital discharge; usually 3-4 days)
- Incidence of adverse drug events(From end of anesthesia to hospital discharge; usually 3-4 days)
- Proportion of clinical decision support tool recommendations that were acknowledged and accepted by provider(From end of anesthesia to hospital discharge; usually 3-4 days)
- Length of hospital stay(From end of surgery to hospital discharge; usually 3-4 days)
- Rate of genome tailored prescription changes(From the end of anesthesia up to hospital discharge; usually 3-4 days)
- Reasons for non-adherence to recommendations(From end of anesthesia to hospital discharge; usually 3-4 days)
研究者
Miklos Kertai
Professor of Anesthesiology
Vanderbilt University Medical Center