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

NCT04696172 | Completed

• 1 other identifier: V1.0
• Study Type: observational
• Target: 525
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Respiratory Distress Syndrome

Keywords

Acute Respiratory Distress Syndrome; Biomarkers; Proteomics; Cardiopulmonary Bypass

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Patients undergoing cardiopulmonary bypass (CPB) with postoperative ARDS

Patients undergoing cardiopulmonary bypass (CPB) without postoperative ARDS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing cardiopulmonary bypass (CPB) in cardiac surgery from April 2021 to July 2022, in Wuhan Union hospital

You may qualify if:

• Selective operation;
• Cardiac surgery with cardiopulmonary bypass;
• Adult patients over 18 years old;
• Signed informed consent

You may not qualify if:

• 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;

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead
• Wuhan Asia Heart Hospital: collaborator

Study Sites (2)

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

Wuhan, Hubei, 430022, China

Location

Wuhan Asia Heart Hospital

Wuhan, Hubei, 430022, China

Location

Related Publications (1)

• 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.

  PMID: 37528797 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Plasma

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 28, 2020
• First Posted: January 6, 2021
• Study Start: April 1, 2021
• Primary Completion: July 30, 2022
• Study Completion: August 30, 2022
• Last Updated: December 13, 2022

Record last verified: 2022-12

Locations

CN (2)