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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05610475
Other study ID # 20220201
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2022
Est. completion date August 1, 2022

Study information

Verified date October 2022
Source Yangzhou University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date August 1, 2022
Est. primary completion date August 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

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.

Locations

Country Name City State
China the Affiliated Hospital of Yangzhou University Yangzhou Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Yangzhou University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary PaO2/FiO2 ratio The ratio of inspiratory oxygen fraction to oxygen pressure (PaO2/FiO2) was calculated. Change from beginning of CPB to 48 h after CPB
Primary 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.
The 24 and 48 hours after CPB
Secondary 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. The day before CPB and 1, 12, 24, 48 hours after CPB
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