Empagliflozin for Prevention of Acute Kidney Injury in Patients With Type 2 Diabetes Mellitus Undergoing Extracorporeal On-pump CABG: The POST-CABGDM Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 155
- 试验地点
- 1
- 主要终点
- Acute kidney injury
研究概览
简要总结
Introduction: Diabetes Mellitus (DM) is a condition known to be associated with coronary artery disease (CAD) and its role as promoter of atherosclerosis is well stablished. The revascularization surgery is commonly indicated to patients with multivessel coronary disease and kidney injury is a prevalent complication in post operation. This work aims to evaluate the impact of a strategy to control Diabetes Mellitus using inhibitors of sodium-glucose cotransporters (ISGLT2) in diabetics patients with assigned myocardial revascularization with cardiopulmonary bypass
详细描述
Random Prospective Study non-blinded with 144 diabetics patients designated to myocardial revascularization with cardiopulmonary bypass . 72 patients will be randomly set to usual treatment provided by health care service and 72 patients will be randomly assigned treatment based on ISGLT2 (Empaglifozin). Patients will receive treatment as set for 3 months until 3 days prior to surgery. Creatinine levels will be measured immediately after surgery and in the following 3 days in post-op.
To evaluate the possibility to reduce the acute kidney injury in a randomized group treated with therapy based on ISGLT2.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18
- •Type 2 diabetes mellitus
- •Multivessel CAD documented by coronary angiography with formal indication for CRM.
排除标准
- •eGFR <30mL / min / 1.73m2 or dialysis therapy;
- •Inability to sign the informed consent form;
- •Contraindication to CABG on pump;
- •Need for urgent or emergency CABG;
- •Terminal or disabling illness with reduced life expectancy;
- •Pregnancy in progress.
研究组 & 干预措施
SGLT2i (empagliflozin)
Empagliflozin 25 mg 1 time day for three months
干预措施: Empagliflozin 25 MG (Drug)
结局指标
主要结局
Acute kidney injury
时间窗: 3 months
Development of post-CABG acute kidney injury according to RIFFLE or AKIN or KDIGO criteria
次要结局
- Atrial fibrillation(3 months)
- Pulmonary infection(3 months)
- Infection of surgical site(3 months)
- ICU readmission(3 months)
- Need for IV insulin(3 months)
- Myocardial Infarction Type 5(3 months)