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CompletedNCT04696172PBOARDSUpdated Dec 13, 2022

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

An observational study in Acute Respiratory Distress Syndrome, sponsored by Huazhong University of Science and Technology. Completed at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-13.

Sponsored by Huazhong University of Science and Technology · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
525
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Acute Respiratory Distress Syndrome

Keywords

  • Acute Respiratory Distress Syndrome
  • Biomarkers
  • Proteomics
  • Cardiopulmonary Bypass
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In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's enrollment of 525 is above the median of 100 across 540 observational studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

Huazhong University of Science and Technology is the lead sponsor of 241 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

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;
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
525 participants (actual)
Target follow-up
1 Week
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Patients undergoing cardiopulmonary bypass (CPB) with postoperative ARDS
  • Patients undergoing cardiopulmonary bypass (CPB) without postoperative ARDS
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What researchers measure

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

    Time frame: 3 days after operation

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Study locations

2 sites
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
    Wuhan, Hubei 430022, China
  • Wuhan Asia Heart Hospital
    Wuhan, Hubei 430022, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04696172
Lead sponsor
Huazhong University of Science and Technology
Collaborators
Wuhan Asia Heart Hospital
Responsible party
Shanglong Yao (Clinical Professor, Wuhan Union Hospital, China) — Principal investigator
First posted
Jan 6, 2021
Start date
Apr 1, 2021
Primary completion
Jul 30, 2022
Completion
Aug 30, 2022
Last update
Dec 13, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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