PBOARDS
Explore Potential Plasma Biomarkers of Acute Respiratory Distress Syndrome (ARDS) Using Proteomics Analysis in Patients Undergoing Cardiopulmonary Bypass
Sponsor study identifier
observational
525
1 country
2
Study Start
April 1, 2021
Actual (reported)Primary Completion
July 30, 2022
Actual (reported)Study Completion
August 30, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 30, 2022
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 28, 2020
Actual (reported)January 6, 2021
Actual (reported)April 1, 2021
Actual (reported)July 30, 2022
Actual (reported)August 30, 2022
Actual (reported)Number of participants with postoperative ARDS events as assessed by Berlin Definition.
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
3 days after operation
Patients undergoing cardiopulmonary bypass (CPB) in cardiac surgery from April 2021 to July 2022, in Wuhan Union hospital
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Wuhan Asia Heart Hospital
Wuhan, Hubei, 430022, China
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.
Plasma
525 participants (actual enrollment reported by the registry).
First Submitted
December 28, 2020
First Posted
January 6, 2021
Study Start
April 1, 2021
Actual (reported)Treatment of ARDS With Sivelestat Sodium
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Primary Completion
July 30, 2022
Actual (reported)Study Completion
August 30, 2022
Actual (reported)Last Updated
December 13, 2022
Record last verified: 2022-12
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