Serum Level of Calpains Product as a Novel Biomarker of Acute Lung Injury Following Cardiopulmonary Bypass(CPB)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- PaO2/FiO2 ratio
研究概览
简要总结
More than 2 million patients worldwide receive heart surgery every year, majority of these surgical patients will undergo cardiopulmonary bypass. However, the incidence of postoperative acute lung injury due to cardiopulmonary bypass is still as high as 20% to 35%. According to clinical experience, the earlier lung damage is detected, the more successful the treatment will be. On the basis of traditional detection, the investigators found a new indicator, serum calpains, which are easy to obtain and have certain specificity. Importantly, they can predict postoperative acute lung injury within 1 hour after cardiac surgery. It is meaningful that this indicator can provide clinicians with early decision-making advice and immediate treatment for patients who may be at risk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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;
- •Underwent cardiac surgery using CPB technology.
排除标准
- •Patient's lack of consent to participate;
- •Presence of abnormal liver, kidney or other organ function;
- •Pulmonary inflammation, chronic obstructive pulmonary disease or tumors;
- •Underwent cardiac surgery without CPB technology;
- •Postoperative need for extracorporeal membrane oxygenation support.
结局指标
主要结局
PaO2/FiO2 ratio
时间窗: Change from beginning of CPB to 48 h after CPB
The ratio of inspiratory oxygen fraction to oxygen pressure (PaO2/FiO2) was calculated.
lung-injury scores
时间窗: The 24 and 48 hours after CPB
A structured tutorial was used to establish consensus in the interpretation of radiographs for radiographic lung-injury scores, range from 0 to 4. 0: No alveolar consolidation; 1: Alveolar consolidation confined to 1 quadrant; 2: Alveolar consolidation confined to 2 quadrants 3: Alveolar consolidation confined to 3 quadrants; 4: Alveolar consolidation in all 4 quadrants. The higher scores mean a worse outcome.
次要结局
- Perioperative serum calpains' concentrations(The day before CPB and 1, 12, 24, 48 hours after CPB)
研究者
Zhuan Zhang
Director
Yangzhou University