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

NCT ID: NCT04696172

Last Updated: 2022-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

525 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-01

Study Completion Date

2022-08-30

Brief Summary

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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

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Conditions

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Acute Respiratory Distress Syndrome

Keywords

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Acute Respiratory Distress Syndrome Biomarkers Proteomics Cardiopulmonary Bypass

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients undergoing cardiopulmonary bypass (CPB) with postoperative ARDS

No interventions assigned to this group

Patients undergoing cardiopulmonary bypass (CPB) without postoperative ARDS

No interventions assigned to this group

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wuhan Asia Heart Hospital

OTHER

Sponsor Role collaborator

Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Shanglong Yao

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Wuhan, Hubei, China

Site Status

Wuhan Asia Heart Hospital

Wuhan, Hubei, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 37528797 (View on PubMed)

Other Identifiers

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V1.0

Identifier Type: -

Identifier Source: org_study_id