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

Sponsor
Yangzhou University (Other)
Overall Status
Completed
CT.gov ID
NCT05610475
Collaborator
(none)
100
1
2
5.9
16.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: blood cell analysis, blood gas surveillance, chest radiograph and echocardiography
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Diagnostic
Official Title:
Serum Level of Calpains Product as a Novel Biomarker of Acute Lung Injury Following Cardiopulmonary Bypass(CPB)
Actual Study Start Date :
Feb 1, 2022
Actual Primary Completion Date :
Aug 1, 2022
Actual Study Completion Date :
Aug 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Lung injury group

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

Sham Comparator: Non-lung injury group

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 the Affiliated Hospital of Yangzhou University Yangzhou Jiangsu China 225000

Sponsors and Collaborators

  • Yangzhou University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhuan Zhang, Director, Yangzhou University
ClinicalTrials.gov Identifier:
NCT05610475
Other Study ID Numbers:
  • 20220201
First Posted:
Nov 9, 2022
Last Update Posted:
Nov 14, 2022
Last Verified:
Oct 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Zhuan Zhang, Director, Yangzhou University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 14, 2022