Plasma Biomarkers of Cardiopulmonary Bypass Induced Acute Respiratory Distress Syndrome (CPB-ARDS) (PBOARDS)

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: Acute Respiratory Distress Syndrome

• Study Type: Observational
• Enrollment (Actual): 525

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Wuhan Asia Heart Hospital
    • Wuhan, Hubei, China, 430022
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 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

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patients undergoing cardiopulmonary bypass (CPB) with postoperative ARDS
Patients undergoing cardiopulmonary bypass (CPB) without postoperative ARDS

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.	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	3 days after operation

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology
• Collaborators: Wuhan Asia Heart Hospital

Study record dates

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

• Keywords: Biomarkers; Acute Respiratory Distress Syndrome; Proteomics; Cardiopulmonary Bypass
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• 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