Pre-operative Exposure to SGLT2 Inhibitors and Post-operative Acute Renal Failure in Cardiac Surgery: a Retrospective Monocentric Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Post-operative acute kidney injury
研究概览
简要总结
Cardiac surgery with cardiopulmonary bypass exposes patients to the risk of post-operative acute kidney injury. In the specific setting of cardiac surgery, acute kidney injury is often of multifactorial origindue to particular haemodynamic mechanisms, renal hypoxia, or damage linked in the inflammatory reaction or haemolysis (1).
In recent years, inhibitors of the sodium/glucose co-transporter type 2 (SGLT2i) have demonstrated their relevance in reducing the morbidity and mortality associated with chronic or acute heart failure and chronic kidney disease. These drugs were initially developed to optimise glycaemic control in diabetic patients. They are currently recommended as part of the management of diabetic patients at high cardiovascular risk, patients with systolic and/or diastolic heart failure, and patients with chronic kidney disease.
Some pharmacodynamic properties of SGLT2i suggest that they could have a beneficial effect in preventing the onset of acute kidney injury, but also that they could lead to potentially deleterious effects in renal haemodynamic in specific situations.
The aim of the study was to estimate the impact of pre-operative exposure to SGLT2i on the occurrence of post-operative acute kidney injury in high-risk renal patients undergoing cardiac surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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 years
- •Cardiac surgery with cardiopulmonary bypass
- •Presenting a simplified renal risk score ≥ 2 points defined as follows:
- •Pre-operative glomerular filtration rate (≤ 60; ≤ 30 mL/min/1.73m2): 1-2 points
- •Diabetes requiring treatment: 1 point
- •LVEF ≤ 40%: 1 point
- •Previous cardiac surgery: 1 point
- •Pre-operative intra-aortic counter pulsation: 1 point
- •Non elective surgery: 1 point
- •Surgery other than closure of an atrial septal defect or coronary bypass surgery: 1 point
排除标准
- •Haemodialysis prior to surgery
- •Acute kidney injury prior to surgery as defined in the primary endpoint. If this criterion is not available, patients will only be included if glomerular filtration rate estimated by the CKD-EPI formula is ≥75 mL/min/1.73m
- •Death in the operating theatre
- •Opposition of the patient to the use of his/her health data
结局指标
主要结局
Post-operative acute kidney injury
时间窗: Baseline creatinine is defined as the last pre-operative value available in the medical file Variation of the creatinine was explored in the first 7 postoperative days
Serum creatinine increase by 0.3 mg/dl within 48 h OR Serum creatinine ≥ 1.5-1.9 times baseline within 7 days Baseline creatinine is defined as the last pre-operative value available in the medical file
次要结局
未报告次要终点