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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Respiratory Distress Syndrome Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Primary outcomes

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:
- 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

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Collaborators

Wuhan Asia Heart Hospital

Registry information

Official study title

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

Acronym: PBOARDS

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Jan 6, 2021
Registry last updated: Dec 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed