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

Acute Respiratory Distress Syndrome Clinical Trial

— PBOARDS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04696172
• Other study ID #: V1.0
• Status: Completed
• Start date: April 1, 2021
• Est. completion date: August 30, 2022

Study information

• Verified date: December 2022
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 525
• Est. completion date: August 30, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Syndrome

Locations

Country	Name	City	State
China	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	Wuhan Asia Heart Hospital	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology	Wuhan Asia Heart Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 days after operation