Clinical trial NCT05529212: Cardiac Surgery and Postoperative Organ Dysfunction
Official title: Cardiopulmonary Bypass Ischemia/Reperfusion Injury and Postoperative Multiple Organ Dysfunction in Elder Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Complications
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital of Third Military Medical University
First posted: 2022-09-06
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients were screened from the outpatient clinics of the Second Hospital of the Army Medical University who were proposed for mitral valve replacement or mitral valve combined with aortic valve replacement, agreed to participate in this study, and signed an informed consent form.

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.

Eligibility criteria: 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

Primary outcomes:
measure: incidence of postoperative cardiac injury
timeFrame: from the ending of surgery to 7 days after surgery
measure: incidence of postoperative acute kidney injury
timeFrame: from the ending of surgery to 7 days after surgery
measure: incidence of postoperative brain injury
timeFrame: from the ending of surgery to 7 days after surgery
Secondary outcomes:
measure: Incidence of postoperative arrhythmia events
timeFrame: from the ending of surgery to 72 hours after surgery
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The second affiliated hospital of Chongqing medical university
Study officials:
affiliation: Chongqing Medical University, the second affiliated hospital
name: He Huang, MD
role: PRINCIPAL_INVESTIGATOR
References: