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

Primary Purpose

Hypoxemia, ARDS, 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
Zhuan Zhang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypoxemia focused on measuring Hypoxemia, acute lung injury, Cardiopulmonary Bypass, FiO2/PaO2

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Lung injury is defined as lung damage when the patient has an oxygen and index below 300 24 hours after cardiopulmonary bypass

Patients with oxygen and an index above 300 24 hours after cardiopulmonary bypass are defined as non-lung injury

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

Full Information

First Posted
November 23, 2022
Last Updated
December 4, 2022
Sponsor
Zhuan Zhang
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1. Study Identification

Unique Protocol Identification Number
NCT05647382
Brief Title
Soluble VE-cadherin in Prediction and Diagnosis of Early Postoperative Hypoxemia After Cardiopulmonary Bypass
Official Title
Soluble Vascular Endothelial-cadherin in Prediction and Diagnosis of Early Postoperative Hypoxemia After Cardiopulmonary Bypass
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
October 1, 2022 (Actual)
Study Completion Date
November 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhuan Zhang

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxemia, ARDS, Lung Injury, Acute, Cardiopulmonary Bypass
Keywords
Hypoxemia, acute lung injury, Cardiopulmonary Bypass, FiO2/PaO2

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 Description
Lung injury is defined as lung damage when the patient has an oxygen and index below 300 24 hours after cardiopulmonary bypass
Arm Title
Non-lung injury group
Arm Type
Sham Comparator
Arm Description
Patients with oxygen and an index above 300 24 hours after cardiopulmonary bypass are defined as non-lung injury
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
Day 1 after CPB, Day 2 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
Day 1 after CPB, Day 2 after CPB

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 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

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

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