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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05610475
Acronym
CPB
Enrollment
100
Registered
2022-11-09
Start date
2022-02-01
Completion date
2022-08-01
Last updated
2022-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Injury, Acute

Keywords

Cardiopulmonary Bypass, Calpain, Lung injury

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.

Interventions

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.

Sponsors

Yangzhou University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
PaO2/FiO2 ratioChange from beginning of CPB to 48 h after CPBThe ratio of inspiratory oxygen fraction to oxygen pressure (PaO2/FiO2) was calculated.
lung-injury scoresThe 24 and 48 hours after CPBA 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

MeasureTime frameDescription
Perioperative serum calpains' concentrationsThe day before CPB and 1, 12, 24, 48 hours after CPBSerial serum samples were obtained and measured by using a fluorometric kit (Abcam, Cambridge, UK) according to the manufacturer's protocol.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026