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NCT Number: NCT05610475

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

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.

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Key information

Conditions

Lung Injury, Acute Acute Lung Injury Lung Diseases Lung Injury Respiratory Tract Diseases Thoracic Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the Affiliated Hospital of Yangzhou University

Yangzhou, Jiangsu, 225000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. PaO2/FiO2 ratio

    Time frame: Change from beginning of CPB to 48 h after CPB

    The ratio of inspiratory oxygen fraction to oxygen pressure (PaO2/FiO2) was calculated.

  2. lung-injury scores

    Time frame: 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 outcomes

  1. Perioperative serum calpains' concentrations

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yangzhou University

Other

Registry information

Official study title

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

Acronym: CPB

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 9, 2022
Registry last updated
Nov 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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