The Effect of Ulistin on Acute Renal Injury in Patients Undergoing OPCAB (Off Pump Coronary Artery Bypass): a Propensity Score Matched Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 主要终点
- The incidence of acute kidney injury
研究概览
简要总结
Acute kidney injury (AKI) is a frequent complication after cardiac surgery. AKI has been reported as 7-40% depending on the type of surgery, and is known to increase to about 50% when there are risk factors. Cardiac surgery-associated AKI (CSA-AKI) requires cardiac replacement therapy in 1-5% of patients and increases mortality to 1,4%, but the treatment is still unknown. Therefore prevention of occurrence is very important.
Known factors related to the development of CSA-AKI include hemodynamic, inflammatory, metabolic, and nephrotoxic factors, and since there is a close connection between hypotension due to deterioration of cardiac function, preventive measures to prevent hypotension in juicing It is only possible.
To date, strategies to protect kidneys with drugs are very limited. Urinary trypsin inhibitor, ulistine, has anti-inflammatory and antioxidant effects, so it has been reported to protect against renal ischemia/reperfusion injury. Various studies have been attempted to prevent CSA-AKI, but most of them are inflammatory reactions during surgery. It was performed only for surgery with extracorporeal circulation that causes severely.
Therefore, this study would like to verify the effectiveness of ulistine's medicine in the prevention of CSA-AKI in patients undergoing coronary artery bypass surgery without extracorporeal circulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •From January 2015 to June 2020, a retrospective study will be conducted on patients undergoing extracorporeal circulatory coronary artery bypass surgery at Ajou University Hospital.
排除标准
- •Patients who were undergoing renal replacement therapy prior to surgery due to end-stage renal failure are excluded from the study.
研究组 & 干预措施
Ulistin
In the Ulistine administration group, 300,000 KIU was mixed with 100 mL physiological saline and administered over 15 minutes after induction of anesthesia.
Anesthesia induction and maintenance and postoperative recovery management were performed according to the standard anesthesia protocol for off pump coronary artery bypass surgery.
干预措施: Ulinastatin (Drug)
结局指标
主要结局
The incidence of acute kidney injury
时间窗: 7 days after operation
Cr ≥ 0.3 mg/dl within 48 hours after surgery, 1.5 times higher preoperative value within 7 days, urine volume \<0.5 ml/kg for 6 hours after surgery
次要结局
未报告次要终点
研究者
Jiyoung Yoo
Assistant professor
Ajou University School of Medicine
