Cardiac Surgery and Postoperative Organ Dysfunction

NCT ID: NCT05529212

Last Updated: 2022-09-06

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

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-16

Study Completion Date

2023-11-30

Brief Summary

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The aim of the study is to identify the correlation between ischaemia reperfusion injury and postoperative multiorgan damage during cardiopulmonary cardiac surgery; and to investigate biomarkers that can predict postoperative organ damage in cardiac surgery.

Detailed Description

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This study proposes to observe multi-organ functional impairment of the heart, kidney and brain after extracorporeal circulation in a prospective study of clinical patients; to obtain markers with diagnostic and predictive efficacy by collecting pre and postoperative serum and heart and ear tissue samples from patients with postoperative organ functional impairment, performing combined proteomic and metabolomic analyses, and by analysing them with detailed postoperative clinical prognostic data using machine learning algorithms.

Conditions

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Postoperative Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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ischemic reperfusion injury

ischemic reperfusion injury is a pathological process in which the ischemic myocardium is restored to normal perfusion, but the tissue damage is progressively aggravated when the coronary artery supply is completely blocked after cardiopulmonary bypass surgery and then recanalised at a certain time.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Age ≥50 years; patients requiring mitral valve replacement surgery or mitral valve plus aortic valve replacement under cardiopulmonary bypass
2. Agreed to participate in this study, and signed the informed consent form.

Exclusion Criteria

1. History of neurological disease (stroke, reversible ischemic hypoxia, transient ischemic attack, or Neurodegeneration) ;
2. Patients with severe preoperative renal insufficiency (serum creatinine \> 442 μmol/L or need renal replacement therapy) ,
3. liver dysfunction (Child-Pugh grade C)
4. myocardial infarction within 4 weeks
5. ASA grade ≥ V
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital of Third Military Medical University

OTHER

Sponsor Role collaborator

The Second Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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He Huang, MD

Role: PRINCIPAL_INVESTIGATOR

Chongqing Medical University, the second affiliated hospital

Locations

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The second affiliated hospital of Chongqing medical university

Chongqing, , China

Site Status

Countries

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China

Central Contacts

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Qiao Guo, MD

Role: CONTACT

13637870013

Dagang Wang, MD

Role: CONTACT

+86 023 63693014

Other Identifiers

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Organ Dysfunction during CPB

Identifier Type: -

Identifier Source: org_study_id

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