- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04696172
Plasma Biomarkers of Cardiopulmonary Bypass Induced Acute Respiratory Distress Syndrome (CPB-ARDS) (PBOARDS)
December 11, 2022 updated by: Shanglong Yao, Huazhong University of Science and Technology
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
525
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hubei
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Wuhan, Hubei, China, 430022
- Wuhan Asia Heart Hospital
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Wuhan, Hubei, China, 430022
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients undergoing cardiopulmonary bypass (CPB) in cardiac surgery from April 2021 to July 2022, in Wuhan Union hospital
Description
Inclusion Criteria:
- Selective operation;
- Cardiac surgery with cardiopulmonary bypass;
- Adult patients over 18 years old;
- Signed informed consent
Exclusion Criteria:
- 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;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Patients undergoing cardiopulmonary bypass (CPB) with postoperative ARDS
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Patients undergoing cardiopulmonary bypass (CPB) without postoperative ARDS
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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:
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 |
3 days after operation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2021
Primary Completion (Actual)
July 30, 2022
Study Completion (Actual)
August 30, 2022
Study Registration Dates
First Submitted
December 28, 2020
First Submitted That Met QC Criteria
January 4, 2021
First Posted (Actual)
January 6, 2021
Study Record Updates
Last Update Posted (Actual)
December 13, 2022
Last Update Submitted That Met QC Criteria
December 11, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- V1.0
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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