Impact of Sodium-glucose Cotransporter 2 Inhibitors on Post-operative Atrial Fibrillation in Cardiothoracic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,280
- 试验地点
- 2
- 主要终点
- Incidence of post-operative atrial fibrillation (POAF)
研究概览
简要总结
SGLT2 inhibitors are oral anti-diabetic medications that were found to improve cardiorenal outcomes in patients with type 2 diabetes mellitus (DM), chronic heart failure with reduced and preserved ejection fraction, and chronic kidney disease. Recent evidence suggested that the use of SGLT2 inhibitors resulted in a significant reduction in atrial fibrillation (AF) over a mean follow-up duration of 2.6 years. Given the possible AF protective benefit with SGLT2 inhibitors use.
详细描述
we aim to conduct a retrospective cohort study to evaluate the impact of SGLT2 inhibitors use on post-operative AF (POAF) among patients undergoing cardiothoracic surgery, including coronary artery bypass grafting (CABG), valve replacement, and valve repair over a 6-year period (from 1/06/2017 to 1/07/2023). The follow-up period will be the post-operative hospital stay or 30-days, whichever is shorter, and the data will be obtained from the electronic medical records. The study outcomes will include effectiveness outcomes of incidence of POAF regardless of frequency, duration, or intervention used for termination, incidence of paroxysmal POAF, incidence of paroxysmal POAF requiring pharmacological cardioversion, incidence of hemodynamically unstable POAF requiring electrical cardioversion, incidence of persistent POAF (sustained beyond 7 days), incidence of POAF requiring anticoagulation, ischemic stroke, and safety outcomes of euglycemic diabetic ketoacidosis and urinary tract infections (UTI).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults > 18 years undergoing cardiothoracic surgery, including CABG, mechanical valve replacement, bioprosthetic valve replacement, or valve repair.
- •Use of SGLT2 inhibitors for a minimum of 1 week prior to surgery regardless of DM status.
- •Resumption of SGLT2 inhibitor after stepping down from the intensive care unit.
排除标准
- •Known AF on anticoagulation.
- •Chronic kidney disease with CrCl < 25 mL/min.
研究组 & 干预措施
SGLT2 inhibitors users
Adults undergoing cardiothoracic surgery who had been using SGLT2 inhibitors for a minimum of 1 week before surgery, regardless of diabetes status
干预措施: SGLT2 inhibitor (Drug)
结局指标
主要结局
Incidence of post-operative atrial fibrillation (POAF)
时间窗: 1 month
Confirmed AF after surgery, regardless of frequency, duration, or intervention used for termination
次要结局
- Euglycemic diabetic ketoacidosis(1 month)
- Urinary tract infection(1 month)