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

Not Applicable

Completed

• Conditions: Lung Injury, Acute
• Interventions: Diagnostic Test: blood cell analysis, blood gas surveillance, chest radiograph and echocardiography

• Registration Number: NCT05610475
• Lead Sponsor: Yangzhou University

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-01
• Primary Completion: 2022-08-01
• Study Completion: 2022-08-01
• Status Verified: 2022-10
• Study First Submitted: 2022-10-30
• Study First Submitted QC: 2022-11-03
• Last Update Submitted: 2022-11-08
• Study First Posted: 2022-11-09
• Last Update Posted: 2022-11-14

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-lung injury group	blood cell analysis, blood gas surveillance, chest radiograph and echocardiography	-
Lung injury group	blood cell analysis, blood gas surveillance, chest radiograph and echocardiography	-

Primary Outcome Measures

Name	Time	Method
PaO2/FiO2 ratio	Change from beginning of CPB to 48 h after CPB	The ratio of inspiratory oxygen fraction to oxygen pressure (PaO2/FiO2) was calculated.
lung-injury scores	The 24 and 48 hours 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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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