Serum Level of Calpains Product as a Novel Biomarker of Acute Lung Injury Following Cardiopulmonary Bypass (CPB)

Yangzhou University

Status: Completed

Conditions: Lung Injury, Acute

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05610475

20220201

Details and patient eligibility

About

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 calpains, 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Lung injury group

Active Comparator group

Treatment:

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

Non-lung injury group

Sham Comparator group

Treatment:

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