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Cardiac Surgery and Postoperative Organ Dysfunction

Cardiopulmonary Bypass Ischemia/Reperfusion Injury and Postoperative Multiple Organ Dysfunction in Elder Patients

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05529212
Enrollment
100
Registered
2022-09-06
Start date
2022-09-16
Completion date
2023-11-30
Last updated
2022-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Complications

Brief summary

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

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.

Interventions

PROCEDUREischemic 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.

Sponsors

Second Affiliated Hospital of Third Military Medical University
CollaboratorOTHER
The Second Affiliated Hospital of Chongqing Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
incidence of postoperative cardiac injuryfrom the ending of surgery to 7 days after surgerytroponin I will be tested before and after surgery
incidence of postoperative acute kidney injuryfrom the ending of surgery to 7 days after surgeryrenal function will be tested before and after surgery
incidence of postoperative brain injuryfrom the ending of surgery to 7 days after surgerydeliriumwill be tested before and after surgery

Secondary

MeasureTime frameDescription
Incidence of postoperative arrhythmia eventsfrom the ending of surgery to 72 hours after surgerypostoperative arrhythmia events are recorded according to follow-up visits after surgery

Countries

China

Contacts

Primary ContactQiao Guo, MD
guoqiao@cqmu.edu.cn13637870013
Backup ContactDagang Wang, MD
kuanrenlunli@qq.com+86 023 63693014

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026