High-dose Ulinastatin Improves Postoperative Oxygenation in Patients Undergoing Aortic Valve Surgery With Cardiopulmonary Bypass
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- change of arterial oxygen partial pressure (PaO2)/fraction of inspired oxygen (FiO2) during CPB
研究概览
简要总结
Retrospective study determine whether ulinastatin enhances postoperative pulmonary oxygenation after cardiopulmonary bypass (CPB).
详细描述
This retrospective study evaluate patients who underwent aortic valvular surgery under moderate hypothermic CPB. The patients were classified into two groups: patients in whom high-dose ulinastatin (10,000 U/kg and 5,000 U/kg/h) was administered during CPB (Group-U); and patients in whom ulinastatin was not administered (Group-C). We measured PaO2/FiO2 at the following time points: before CPB (Pre-CPB), 2 hours after weaning from CPB (Post-CPB) and within 6 hours after admission to the ICU. The lengths of ventilator care and ICU stay were also reviewed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who underwent aortic repair or replacement under moderate hypothermic CPB
排除标准
- •Preoperative:
- •< 19 years old, > 85 years old, emergency operation, reoperation, left ventricular ejection fraction < 50%, arrhythmia, ischaemic myocardial disease, uncontrollable hypertension or hypotension, pericardial disease, pre-existing hepatic dysfunction, pre-existing renal dysfunction or underlying lung disease.
- •Intraoperative:
- •intraoperative application of an intra-aortic balloon pump, administration of steroids or tranexamic acid, and transfusion of fresh frozen plasma or platelet concentrates during CPB.
- •Postoperative:
- •reoperation for surgical correction of intractable postoperative bleeding within 2 hours after the end of surgery and transfusion of any banked blood products.
研究组 & 干预措施
control
conventional CPB was applied without ulinastatin treatment
干预措施: control (Drug)
ulinastatin treatment
ulinastatin (10000 U/kg and 5000 U/kg/h) was administered during CPB
干预措施: ulinastatin (Drug)
结局指标
主要结局
change of arterial oxygen partial pressure (PaO2)/fraction of inspired oxygen (FiO2) during CPB
时间窗: before CPB (Day 0), 2hours after CPB(Day 0), within 6hour after admission to intensive care unit(Day 0)
pulmonary oxygenation
次要结局
未报告次要终点
研究者
Tae-Yop Kim, MD PhD
Professor
Konkuk University Medical Center