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Clinical Trials/NCT04696172
NCT04696172
Completed
Not Applicable

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

Huazhong University of Science and Technology2 sites in 1 country525 target enrollmentApril 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Respiratory Distress Syndrome
Sponsor
Huazhong University of Science and Technology
Enrollment
525
Locations
2
Primary Endpoint
Number of participants with postoperative ARDS events as assessed by Berlin Definition.
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2021
End Date
August 30, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Shanglong Yao

Clinical Professor

Wuhan Union Hospital, China

Eligibility Criteria

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;

Outcomes

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: 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

Study Sites (2)

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