Effect of Acetaminophen on the Incidence of Acute Kidney Injury in Patients Undergoing Aortic Surgery With Moderate Hypothermic Circulatory Arrest
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Incidence of acute kidney injury after aortic surgery with moderate hypothermic circulatory arrest
研究概览
简要总结
Acute kidney injury is commonly accompanied major complication after aortic surgery.
Cardipulmonary bypass lyses erythrocyte and induces lipid peroxidation. This increases plasma free hemoglobin, F2-isoprostane, and isofuran concentration. Cell free hemoglobin have been reported to be associated with poor prognosis such as acute kidney injury, myocardial infarction, and death.
Acetaminophen is reported to attenuate hemeprotein mediated lipid peroxidation. Thus, investigators hypothesized that acetaminophen might have protective effect on the incidence of acute kidney injury in patients undergoing aortic surgery with moderate hypothermic circulatory arrest.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing aortic surgery with moderate hypothermic circulatory arrest.
排除标准
- •patients with chronic kidney disease or with dialysis, eGFR < 15ml/min/1.73m2
- •allergy to acetaminophen or propacetamol HCl
- •history of liver cirrhosis or total bilirubin > 2.0mg/dL
- •patients taking acetaminophen or diclofenac 4) patients who cannot understand informed consent
研究组 & 干预措施
Acetaminophen group
patients receiving acetaminophen
干预措施: Acetaminophen (Drug)
Placebo group
patients receiving equal amount of normal saline
干预措施: Placebo (Other)
结局指标
主要结局
Incidence of acute kidney injury after aortic surgery with moderate hypothermic circulatory arrest
时间窗: Postoperative 7 days
Compare the incidence of acute kidney injury within 7 days after surgery. Acute kidney injury is defined using KDIGO criteria.
次要结局
未报告次要终点
研究者
Sung Yeon Ham
Assistant Professor
Gangnam Severance Hospital