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

NCT05610475 | Completed

• 1 other identifier: 20220201
• 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 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.

Conditions

Lung Injury, Acute

Keywords

Cardiopulmonary Bypass; Calpain; Lung injury

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Perioperative serum calpains' concentrations

  The day before CPB and 1, 12, 24, 48 hours after CPB

Study Arms (2)

Lung injury group

ACTIVE COMPARATOR

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

Non-lung injury group

SHAM COMPARATOR

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+
• 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

• Yangzhou University: lead

Study Sites (1)

the Affiliated Hospital of Yangzhou University

Yangzhou, Jiangsu, 225000, China

Location

Related Publications (1)

• Yi C, Chen F, Ma R, Fu Z, Song M, Zhang Z, Chen L, Tang X, Lu P, Li B, Zhang Q, Song Q, Zhu G, Wang W, Wang Q, Wang X. Serum level of calpains product as a novel biomarker of acute lung injury following cardiopulmonary bypass. Front Cardiovasc Med. 2022 Nov 16;9:1000761. doi: 10.3389/fcvm.2022.1000761. eCollection 2022.

  PMID: 36465445 DERIVED

MeSH Terms

Conditions

Acute Lung Injury; Lung Injury

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Thoracic Injuries; Wounds and Injuries

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: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: October 30, 2022
• First Posted: November 9, 2022
• Study Start: February 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: November 14, 2022

Record last verified: 2022-10

Locations

CN (1)