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

Study Overview
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Brief Summary
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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.

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

Conditions
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Lung Injury, Acute

Intervention / Treatment
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* Diagnostic Test: blood cell analysis, blood gas surveillance, chest radiograph and echocardiography


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lung injury group<br> | Diagnostic Test: blood cell analysis, blood gas surveillance, chest radiograph and echocardiography<br>* 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.<br>|
| Sham Comparator: Non-lung injury group<br> | Diagnostic Test: blood cell analysis, blood gas surveillance, chest radiograph and echocardiography<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PaO2/FiO2 ratio | The ratio of inspiratory oxygen fraction to oxygen pressure (PaO2/FiO2) was calculated. | Change from beginning of CPB to 48 h 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. | The 24 and 48 hours after CPB | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative serum calpains' concentrations | Serial serum samples were obtained and measured by using a fluorometric kit (Abcam, Cambridge, UK) according to the manufacturer's protocol. | The day before CPB and 1, 12, 24, 48 hours after CPB | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiopulmonary Bypass, Calpain, Lung injury