Serum Level of Calpains Product as a Novel Biomarker of Acute Lung Injury Following Cardiopulmonary Bypass(CPB)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- PaO2/FiO2 ratio
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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.
Outcomes
Primary Outcomes
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.
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
- Perioperative serum calpains' concentrations(The day before CPB and 1, 12, 24, 48 hours after CPB)
Investigators
Zhuan Zhang
Director
Yangzhou University