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

ARDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05647382
• Other study ID #: 20221123
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: November 1, 2022

Study information

• Verified date: December 2022
• Source: Yangzhou University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age = 18 years;
• Underwent cardiac surgery using CPB technology.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Acute Lung Injury
• ARDS
• Cardiopulmonary Bypass
• Hypoxemia
• Hypoxia
• Lung Injury
• Lung Injury, Acute

Intervention

Diagnostic Test:
• blood cell analysis, blood gas surveillance, chest radiograph and echocardiography
Laboratory parameters of all postoperative patients including blood cell analysis, blood gas surveillance, liver, and kidney function alone with chest radiograph and echocardiography were dynamically monitored.

Locations

Country	Name	City	State
China	the Affiliated Hospital of Yangzhou University	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Zhuan Zhang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PaO2/FiO2 ratio	The ratio of inspiratory oxygen fraction to oxygen pressure (PaO2/FiO2) was calculated	Day 1 after CPB, Day 2 after CPB
Primary	lung-injury scores	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.	Day 1 after CPB, Day 2 after CPB