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Soluble VE-cadherin in Prediction and Diagnosis of Early Postoperative Hypoxemia After Cardiopulmonary Bypass

Soluble Vascular Endothelial-cadherin in Prediction and Diagnosis of Early Postoperative Hypoxemia After Cardiopulmonary Bypass

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05647382
Enrollment
100
Registered
2022-12-12
Start date
2022-02-01
Completion date
2022-11-01
Last updated
2022-12-12

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

Conditions

ARDS, Cardiopulmonary Bypass, Hypoxemia, Lung Injury, Acute

Keywords

Hypoxemia, acute lung injury, Cardiopulmonary Bypass, FiO2/PaO2

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 soluble vascular endothelial-cadherin, 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

Zhuan Zhang
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 80 Years
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 ratioDay 1 after CPB, Day 2 after CPBThe ratio of inspiratory oxygen fraction to oxygen pressure (PaO2/FiO2) was calculated
lung-injury scoresDay 1 after CPB, Day 2 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026