Cardiac Surgery and Postoperative Organ Dysfunction

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Complications
• Intervention / Treatment: Procedure: ischemic reperfusion injury

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Qiao Guo, MD; Phone Number: 13637870013; Email: guoqiao@cqmu.edu.cn

Study Locations

• China
  • Chongqing, China
    • The Second Affiliated Hospital of Chongqing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of postoperative cardiac injury	troponin I will be tested before and after surgery	from the ending of surgery to 7 days after surgery
incidence of postoperative acute kidney injury	renal function will be tested before and after surgery	from the ending of surgery to 7 days after surgery
incidence of postoperative brain injury	deliriumwill be tested before and after surgery	from the ending of surgery to 7 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative arrhythmia events	postoperative arrhythmia events are recorded according to follow-up visits after surgery	from the ending of surgery to 72 hours after surgery

Collaborators and Investigators

• Sponsor: The Second Affiliated Hospital of Chongqing Medical University
• Collaborators: Second Affiliated Hospital of Third Military Medical University
• Investigators: Principal Investigator: He Huang, MD, Chongqing Medical University, the second affiliated hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 16, 2022
• Primary Completion (ANTICIPATED): September 30, 2023
• Study Completion (ANTICIPATED): November 30, 2023

Study Registration Dates

• First Submitted: August 30, 2022
• First Submitted That Met QC Criteria: September 2, 2022
• First Posted (ACTUAL): September 6, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 6, 2022
• Last Update Submitted That Met QC Criteria: September 2, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: Organ Dysfunction during CPB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The individual participant data for this study is available from the sponsor on reasonable request through email.
• IPD Sharing Time Frame: Within five years
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No