Serum Level of Calpains Product as a Novel Biomarker of Acute Lung Injury Following Cardiopulmonary Bypass (CPB)
Primary Purpose
Lung Injury, Acute
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
blood cell analysis, blood gas surveillance, chest radiograph and echocardiography
Sponsored by
About this trial
This is an interventional diagnostic trial for Lung Injury, Acute focused on measuring Cardiopulmonary Bypass, Calpain, Lung injury
Eligibility Criteria
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.
Sites / Locations
- the Affiliated Hospital of Yangzhou University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Lung injury group
Non-lung injury group
Arm Description
Outcomes
Primary Outcome Measures
PaO2/FiO2 ratio
The ratio of inspiratory oxygen fraction to oxygen pressure (PaO2/FiO2) was calculated.
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05610475
Brief Title
Serum Level of Calpains Product as a Novel Biomarker of Acute Lung Injury Following Cardiopulmonary Bypass
Acronym
CPB
Official Title
Serum Level of Calpains Product as a Novel Biomarker of Acute Lung Injury Following Cardiopulmonary Bypass(CPB)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yangzhou University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Injury, Acute
Keywords
Cardiopulmonary Bypass, Calpain, Lung injury
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lung injury group
Arm Type
Active Comparator
Arm Title
Non-lung injury group
Arm Type
Sham Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
blood cell analysis, blood gas surveillance, chest radiograph and echocardiography
Intervention Description
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 Outcome Measure Information:
Title
PaO2/FiO2 ratio
Description
The ratio of inspiratory oxygen fraction to oxygen pressure (PaO2/FiO2) was calculated.
Time Frame
Change from beginning of CPB to 48 h after CPB
Title
lung-injury scores
Description
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.
Time Frame
The 24 and 48 hours after CPB
Secondary Outcome Measure Information:
Title
Perioperative serum calpains' concentrations
Description
Serial serum samples were obtained and measured by using a fluorometric kit (Abcam, Cambridge, UK) according to the manufacturer's protocol.
Time Frame
The day before CPB and 1, 12, 24, 48 hours after CPB
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
the Affiliated Hospital of Yangzhou University
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225000
Country
China
12. IPD Sharing Statement
Learn more about this trial
Serum Level of Calpains Product as a Novel Biomarker of Acute Lung Injury Following Cardiopulmonary Bypass
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