Cardiac Surgery and Postoperative Organ Dysfunction

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05529212
• Other study ID #: Organ Dysfunction during CPB
• Status: Not yet recruiting
• Start date: September 16, 2022
• Est. completion date: November 30, 2023

Study information

• Verified date: September 2022
• Source: The Second Affiliated Hospital of Chongqing Medical University
• Contact: Qiao Guo, MD
• Phone: 13637870013
• Email: guoqiao[@]cqmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: November 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Complications

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
China	The second affiliated hospital of Chongqing medical university	Chongqing

Sponsors (2)

Lead Sponsor	Collaborator
The Second Affiliated Hospital of Chongqing Medical University	Second Affiliated Hospital of Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of postoperative cardiac injury	troponin I will be tested before and after surgery	from the ending of surgery to 7 days after surgery
Primary	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
Primary	incidence of postoperative brain injury	deliriumwill be tested before and after surgery	from the ending of surgery to 7 days after surgery
Secondary	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