Skip to main content
Clinical Trials/NCT05529212
NCT05529212
Not yet recruiting
Not Applicable

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

The Second Affiliated Hospital of Chongqing Medical University1 site in 1 country100 target enrollmentSeptember 16, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Complications
Sponsor
The Second Affiliated Hospital of Chongqing Medical University
Enrollment
100
Locations
1
Primary Endpoint
incidence of postoperative cardiac injury
Status
Not yet recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 16, 2022
End Date
November 30, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

incidence of postoperative cardiac injury

Time Frame: from the ending of surgery to 7 days after surgery

troponin I will be tested before and after surgery

incidence of postoperative brain injury

Time Frame: from the ending of surgery to 7 days after surgery

deliriumwill be tested before and after surgery

incidence of postoperative acute kidney injury

Time Frame: from the ending of surgery to 7 days after surgery

renal function will be tested before and after surgery

Secondary Outcomes

  • Incidence of postoperative arrhythmia events(from the ending of surgery to 72 hours after surgery)

Study Sites (1)

Loading locations...

Similar Trials