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

Completed

• Conditions: Acute Respiratory Distress Syndrome

• Registration Number: NCT04696172
• Lead Sponsor: Huazhong University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-28
• Study First Submitted QC: 2021-01-04
• Study First Posted: 2021-01-06
• Study Start: 2021-04-01
• Primary Completion: 2022-07-30
• Study Completion: 2022-08-30
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-11
• Last Update Posted: 2022-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 525

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with postoperative ARDS events as assessed by Berlin Definition.	3 days after operation	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

Trial Locations

Locations (2)

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

Wuhan Asia Heart Hospital; 🇨🇳 Wuhan, Hubei, China