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临床试验/NCT04473144
NCT04473144Unknown不适用

The Effect of Ulistin on Acute Renal Injury in Patients Undergoing OPCAB (Off Pump Coronary Artery Bypass): a Propensity Score Matched Study

Ajou University School of Medicine0 个研究点目标入组 500 人开始时间: 2020年8月1日最近更新:
适应症
干预措施
相关药物

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

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

Sham Comparator

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

发起方
Ajou University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jiyoung Yoo

Assistant professor

Ajou University School of Medicine

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