Prevention of cardiac surgery-associated acute kidney injury through the use of sodium-glucose cotransporter 2 inhibitors
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 608
- 试验地点
- 1
- 主要终点
- Composite endpoint of worsening of renal function, defined as a decline in estimated glomerular filtration rate (eGFR) of ≥25%, renal replacement therapy initiation or death during the first 90 days following surgery
研究概览
简要总结
The primary aim of the VERTIGO trial is to evaluate whether once daily perioperative empagliflozin reduces the incidence of acute kidney injury, compared with placebo, in patients requiring elective cardiac surgery with extracorporeal circulation.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age; 2) Requiring elective cardiac surgery with ECC; 3) Able to understand the aim of the study and to provide written informed consent
排除标准
- •Emergent surgery; 2) Endocarditis; 3) Patients awaiting heart transplantation; 4) Planned use of intra-aortic balloon pump; 5) Type 1 diabetes; 6) Chronic kidney disease with eGFR <30 mL/min/1.73 m2; 7) Severe liver dysfunction (ALT or AST >3 times above the upper limit of normality); 8) Active cancer; 9) Active treatment with any SGLT2i; 10) Known allergy to empagliflozin, any other SGLT2i or any of its excipients; 11) Solid organ transplant recipients; 12) Pregnant or lactating women; 13) Patients who are participating in another clinical trial
结局指标
主要结局
Composite endpoint of worsening of renal function, defined as a decline in estimated glomerular filtration rate (eGFR) of ≥25%, renal replacement therapy initiation or death during the first 90 days following surgery
Composite endpoint of worsening of renal function, defined as a decline in estimated glomerular filtration rate (eGFR) of ≥25%, renal replacement therapy initiation or death during the first 90 days following surgery
次要结局
未报告次要终点
研究者
Armando Coca
Scientific
Hospital Clinico Universitario De Valladolid