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

NCT ID: NCT05647382

Last Updated: 2022-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2022-11-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

Lung injury group

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Non-lung injury group

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

Group Type: SHAM_COMPARATOR

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

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhuan Zhang

OTHER

Sponsor Role: lead

Responsible Party

Zhuan Zhang

Director

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

the Affiliated Hospital of Yangzhou University

Yangzhou, Jiangsu, China

Countries

China

Other Identifiers

20221123

Identifier Type: -

Identifier Source: org_study_id