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

Explore Potential Plasma Biomarkers of Acute Respiratory Distress Syndrome (ARDS) Using Proteomics Analysis in Patients Undergoing Cardiopulmonary Bypass

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04696172
Acronym
PBOARDS
Enrollment
525
Registered
2021-01-06
Start date
2021-04-01
Completion date
2022-08-30
Last updated
2022-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome

Keywords

Acute Respiratory Distress Syndrome, Biomarkers, Proteomics, Cardiopulmonary Bypass

Brief 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. 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.

Interventions

None listed

Sponsors

Wuhan Asia Heart Hospital
CollaboratorOTHER
Huazhong University of Science and Technology
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with postoperative ARDS events as assessed by Berlin Definition.3 days after operationThe 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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026