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

Not Applicable

Completed

• Conditions: ARDS; Lung Injury, Acute; Hypoxemia; Cardiopulmonary Bypass
• Interventions: Diagnostic Test: blood cell analysis, blood gas surveillance, chest radiograph and echocardiography

• Registration Number: NCT05647382
• Lead Sponsor: Zhuan Zhang

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-01
• Primary Completion: 2022-10-01
• Study Completion: 2022-11-01
• Study First Submitted: 2022-11-23
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-04
• Last Update Submitted: 2022-12-04
• Study First Posted: 2022-12-12
• Last Update Posted: 2022-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lung injury group	blood cell analysis, blood gas surveillance, chest radiograph and echocardiography	Lung injury is defined as lung damage when the patient has an oxygen and index below 300 24 hours after cardiopulmonary bypass
Non-lung injury group	blood cell analysis, blood gas surveillance, chest radiograph and echocardiography	Patients with oxygen and an index above 300 24 hours after cardiopulmonary bypass are defined as non-lung injury

Primary Outcome Measures

Name	Time	Method
PaO2/FiO2 ratio	Day 1 after CPB, Day 2 after CPB	The ratio of inspiratory oxygen fraction to oxygen pressure (PaO2/FiO2) was calculated
lung-injury scores	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.

Trial Locations

Locations (1)

the Affiliated Hospital of Yangzhou University; 🇨🇳 Yangzhou, Jiangsu, China