Acute Respiratory Distress SyndromePBOARDSNCT04696172
Plasma Biomarkers of Cardiopulmonary Bypass Induced Acute Respiratory Distress Syndrome (CPB-ARDS)
An observational study of Acute Respiratory Distress Syndrome, run by Huazhong University of Science and Technology at 2 sites in China.
Trial summary
The investigators aimed to establish a prospective cohort of patients undergoing cardiopulmonary bypass (CPB) in cardiac surgery from April 2021 to September 2022, in Wuhan. The ARDS events, ventilation time, time of extubation, oxygenation index for 3 days after operation were observed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- How many people
- 525 participants
- Where
- 2 sitesChina
- Study dates
- 1 Apr 2021to 30 Aug 2022
- How long will I take part?
- 1 Week
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing cardiopulmonary bypass (CPB) in cardiac surgery from April 2021 to July 2022, in Wuhan Union hospital
Who may be able to join
- Selective operation;
- Cardiac surgery with cardiopulmonary bypass;
- Adult patients over 18 years old;
- Signed informed consent
Who cannot join
- patients who refuse to sign the informed consent form or the attending physician refuses the patient to join the study;
- non elective surgery (surgery at non-elective time or emergency surgery);
- preoperative pulmonary insufficiency, pulmonary hypertension and pulmonary inflammation;
- the absence of any specimen and clinical data;
- patients who failed the operation, needed extracorporeal membrane oxygenation support or underwent CPB operation again within 3 days after operation;
Trial locations and contacts
2 sites in 1 country.
China2 sites
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Wuhan Asia Heart Hospital
Wuhan, Hubei, 430022
About this study
Official title: Explore Potential Plasma Biomarkers of Acute Respiratory Distress Syndrome (ARDS) Using Proteomics Analysis in Patients Undergoing Cardiopulmonary Bypass
The investigators aimed to establish a prospective cohort of patients undergoing cardiopulmonary bypass (CPB) in cardiac surgery from April 2021 to September 2022, in Wuhan. The ARDS events, ventilation time, time of extubation, oxygenation index for 3 days after operation were observed. Plasma samples were collected before CPB, and several time points after CPB. Dynamic differential proteins of ARDS after CPB were screened by DIA (Data independent acquisition) proteomics. Quantitative protein marker concentration was used to predict the occurrence of ARDS after operation, the model discrimination and calibration was assessed.
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- Acute Respiratory Distress Syndrome, Biomarkers, Proteomics, Cardiopulmonary Bypass
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing cardiopulmonary bypass (CPB) with postoperative ARDS | Not described | |
| Patients undergoing cardiopulmonary bypass (CPB) without postoperative ARDS | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with postoperative ARDS events as assessed by Berlin Definition.
The Berlin Definition of Acute Respiratory Distress Syndrome:
- Timing: Within 1 week of a known clinical insult or new or worsening respiratory symptoms;
- Chest imaging: Bilateral opacities-not fully explained by effusions, lobar/lung collapse, or nodules;
- Origin of edema: Respiratory failure not fully explained by cardiac failure or fluid overload. Need objective assessment (eg, echocardiography) to exclude hydrostatic edema if no risk factor present;
- Oxygenation:
Mild 200 mm Hg <PaO2/FIO2≤ 300 mm Hg with PEEP or CPAP ≥5 cm H2O; Moderate 100 mm Hg <PaO2/FIO2≤ 200 mm Hg with PEEP ≥5 cm H2O Severe PaO2/FIO2≤ 100 mm Hg with PEEP ≥5 cm H2O
Measured: 3 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start1 Apr 2021
- Primary completion30 Jul 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 525 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhan Asia Heart Hospital
- Responsible party
- Principal investigator, Shanglong Yao, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04696172
- Sponsor's protocol ID
- V1.0
- Acronym
- PBOARDS
- Status last verified
- Dec 2022
- First submitted
- 28 Dec 2020
- Last updated
- 13 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang Y, Chen L, Yao C, Wang T, Wu J, Shang Y, Li B, Xia H, Huang S, Wang F, Wen S, Huang S, Lin Y, Dong N, Yao S. Early plasma proteomic biomarkers and prediction model of acute respiratory distress syndrome after cardiopulmonary bypass: a prospective nested cohort study. Int J Surg. 2023 Sep 1;109(9):2561-2573. doi: 10.1097/JS9.0000000000000434.
PubMed 37528797
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explore Potential Plasma Biomarkers of Acute Respiratory Distress Syndrome (ARDS) Using Proteomics Analysis in Patients Undergoing Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT04696172
- Acronym / sponsor ID
- PBOARDS / V1.0
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- Acute Respiratory Distress Syndrome, Biomarkers, Proteomics, Cardiopulmonary Bypass
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 525 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Wuhan Asia Heart Hospital
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 6 Jan 2021 (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.
The investigators aimed to establish a prospective cohort of patients undergoing cardiopulmonary bypass (CPB) in cardiac surgery from April 2021 to September 2022, in Wuhan. The ARDS events, ventilation time, time of extubation, oxygenation index for 3 days after operation were observed. Plasma samples were collected before CPB, and several time points after CPB. Dynamic differential proteins of ARDS after CPB were screened by DIA (Data independent acquisition) proteomics. Quantitative protein marker concentration was used to predict the occurrence of ARDS after operation, the model discrimination and calibration was assessed.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing cardiopulmonary bypass (CPB) with postoperative ARDS | – | – |
| Patients undergoing cardiopulmonary bypass (CPB) without postoperative ARDS | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing cardiopulmonary bypass (CPB) in cardiac surgery from April 2021 to July 2022, in Wuhan Union hospital
Key inclusion criteria (4 listed)
- Selective operation;
- Cardiac surgery with cardiopulmonary bypass;
- Adult patients over 18 years old;
- Signed informed consent
Key exclusion criteria (5 listed)
- patients who refuse to sign the informed consent form or the attending physician refuses the patient to join the study;
- non elective surgery (surgery at non-elective time or emergency surgery);
- preoperative pulmonary insufficiency, pulmonary hypertension and pulmonary inflammation;
- the absence of any specimen and clinical data;
- patients who failed the operation, needed extracorporeal membrane oxygenation support or underwent CPB operation again within 3 days after operation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with postoperative ARDS events as assessed by Berlin Definition.
Time frame: 3 days after operation
The Berlin Definition of Acute Respiratory Distress Syndrome: 1. Timing: Within 1 week of a known clinical insult or new or worsening respiratory symptoms; 2. Chest imaging: Bilateral opacities-not fully explained by effusions, lobar/lung collapse, or nodules; 3. Origin of edema: Respiratory failure not fully explained by cardiac failure or fluid overload. Need objective assessment (eg, echocardiography) to exclude hydrostatic edema if no risk factor present; 4. Oxygenation: Mild 200 mm Hg <PaO2/FIO2≤ 300 mm Hg with PEEP or CPAP ≥5 cm H2O; Moderate 100 mm Hg <PaO2/FIO2≤ 200 mm Hg with PEEP ≥5 cm H2O Severe PaO2/FIO2≤ 100 mm Hg with PEEP ≥5 cm H2O
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 13 Dec 2022.
- Derived from this study: PubMed 37528797Wang Y, Chen L, Yao C, Wang T, Wu J, Shang Y, Li B, Xia H, Huang S, Wang F, Wen S, Huang S, Lin Y, Dong N, Yao S. Early plasma proteomic biomarkers and prediction model of acute respiratory distress syndrome after cardiopulmonary bypass: a prospective nested cohort study. Int J Surg. 2023 Sep 1;109(9):2561-2573. doi: 10.1097/JS9.0000000000000434.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome, run by Huazhong University of Science and Technology at 2 sites 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 4 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 13 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 2 sites 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. 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?
Number of participants with postoperative ARDS events as assessed by Berlin Definition. (time frame: 3 days after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04696172, which also lists 1 linked publication.
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 13 Dec 2022.