HypoxemiaNCT05647382
Soluble VE-cadherin in Prediction and Diagnosis of Early Postoperative Hypoxemia After Cardiopulmonary Bypass
A study testing blood cell analysis, blood gas surveillance, chest radiograph and echocardiography in people with Hypoxemia and ARDS, run by Zhuan Zhang at 1 site in China.
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%. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypoxemia, ARDS, Lung Injury, Acute
- What is being tested?
- blood cell analysis, blood gas surveillance, chest radiograph and echocardiography
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2022to 1 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years;
- Underwent cardiac surgery using CPB technology.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
the Affiliated Hospital of Yangzhou University
Yangzhou, Jiangsu, 225000
About this study
Official title: Soluble Vascular Endothelial-cadherin in Prediction and Diagnosis of Early Postoperative Hypoxemia After Cardiopulmonary Bypass
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.
- Conditions
- Hypoxemia, ARDS, Lung Injury, Acute, Cardiopulmonary Bypass
- Being tested
- blood cell analysis, blood gas surveillance, chest radiograph and echocardiography
- Keywords
- Hypoxemia, acute lung injury, Cardiopulmonary Bypass, FiO2/PaO2
- Medical subject headings
- Hypoxia, Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood cell analysis, blood gas surveillance, chest radiograph and echocardiographyDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Lung injury group | Active comparator | Lung injury is defined as lung damage when the patient has an oxygen and index below 300 24 hours after cardiopulmonary bypass Receives: Diagnostic Test: blood cell analysis, blood gas surveillance, chest radiograph and echocardiography |
| Non-lung injury group | Sham comparator | Patients with oxygen and an index above 300 24 hours after cardiopulmonary bypass are defined as non-lung injury Receives: Diagnostic Test: blood cell analysis, blood gas surveillance, chest radiograph and echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
PaO2/FiO2 ratio
The ratio of inspiratory oxygen fraction to oxygen pressure (PaO2/FiO2) was calculated
Measured: Day 1 after CPB, Day 2 after CPB
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.
Measured: Day 1 after CPB, Day 2 after CPB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start1 Feb 2022
- Primary completion1 Oct 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhuan Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhuan Zhang, Yangzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647382
- Sponsor's protocol ID
- 20221123
- Status last verified
- Dec 2022
- First submitted
- 23 Nov 2022
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soluble Vascular Endothelial-cadherin in Prediction and Diagnosis of Early Postoperative Hypoxemia After Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT05647382
- Acronym / sponsor ID
- 20221123
- Conditions
- Hypoxemia, ARDS, Lung Injury, Acute, Cardiopulmonary Bypass
- Keywords
- Hypoxemia, acute lung injury, Cardiopulmonary Bypass, FiO2/PaO2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Zhuan ZhangUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lung injury group | Active comparator | Diagnostic Test: blood cell analysis, blood gas surveillance, chest radiograph and echocardiographyLung injury is defined as lung damage when the patient has an oxygen and index below 300 24 hours after cardiopulmonary bypass |
| Non-lung injury group | Sham comparator | Diagnostic Test: blood cell analysis, blood gas surveillance, chest radiograph and echocardiographyPatients with oxygen and an index above 300 24 hours after cardiopulmonary bypass are defined as non-lung injury |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years;
- Underwent cardiac surgery using CPB technology.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood cell analysis, blood gas surveillance, chest radiograph and echocardiographyLaboratory 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. | Diagnostic test | Lung injury group, Non-lung injury group |
Primary outcome
PaO2/FiO2 ratio
Time frame: Day 1 after CPB, Day 2 after CPB
The ratio of inspiratory oxygen fraction to oxygen pressure (PaO2/FiO2) was calculated
lung-injury scores
Time frame: Day 1 after CPB, Day 2 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood cell analysis, blood gas surveillance, chest radiograph and echocardiography in people with Hypoxemia and ARDS, run by Zhuan Zhang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PaO2/FiO2 ratio (time frame: Day 1 after CPB, Day 2 after CPB). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2022.