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临床试验/NCT05647382
NCT05647382已完成不适用

Soluble Vascular Endothelial-cadherin in Prediction and Diagnosis of Early Postoperative Hypoxemia After Cardiopulmonary Bypass

Zhuan Zhang1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年2月1日最近更新:
适应症

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 soluble vascular endothelial-cadherin, 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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

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: Day 1 after CPB, Day 2 after CPB

The ratio of inspiratory oxygen fraction to oxygen pressure (PaO2/FiO2) was calculated

lung-injury scores

时间窗: Day 1 after CPB, Day 2 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

未报告次要终点

研究者

发起方
Zhuan Zhang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Zhuan Zhang

Director

Yangzhou University

研究点 (1)

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