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

NCT05647382 | Completed

• 1 other identifier: 20221123
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxemia; ARDS; Lung Injury, Acute; Cardiopulmonary Bypass

Keywords

Hypoxemia; acute lung injury; Cardiopulmonary Bypass; FiO2/PaO2

Outcome Measures

Primary Outcomes (2)

• PaO2/FiO2 ratio

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

  Day 1 after CPB, Day 2 after CPB

• 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

Study Arms (2)

Lung injury group

ACTIVE COMPARATOR

Lung injury is defined as lung damage when the patient has an oxygen and index below 300 24 hours after cardiopulmonary bypass

Diagnostic Test: blood cell analysis, blood gas surveillance, chest radiograph and echocardiography

Non-lung injury group

SHAM COMPARATOR

Patients with oxygen and an index above 300 24 hours after cardiopulmonary bypass are defined as non-lung injury

Diagnostic Test: blood cell analysis, blood gas surveillance, chest radiograph and echocardiography

Interventions

blood cell analysis, blood gas surveillance, chest radiograph and echocardiography DIAGNOSTIC_TEST

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.

Lung injury group; Non-lung injury group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhuan Zhang: lead

Study Sites (1)

the Affiliated Hospital of Yangzhou University

Yangzhou, Jiangsu, 225000, China

Location

MeSH Terms

Conditions

Hypoxia; Acute Lung Injury

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Injury; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 12, 2022
• Study Start: February 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: November 1, 2022
• Last Updated: December 12, 2022

Record last verified: 2022-12

Locations

CN (1)