Cardiac Surgery and Postoperative Organ Dysfunction

Not yet recruiting

• Conditions: Postoperative Complications

• Registration Number: NCT05529212
• Lead Sponsor: The Second Affiliated Hospital of Chongqing Medical University

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.

Study Timeline

• Study First Submitted: 2022-08-30
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-02
• Last Update Submitted: 2022-09-02
• Study First Posted: 2022-09-06
• Last Update Posted: 2022-09-06
• Study Start: 2022-09-16
• Primary Completion: 2023-09-30
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Incidence of postoperative arrhythmia events	from the ending of surgery to 72 hours after surgery	postoperative arrhythmia events are recorded according to follow-up visits after surgery

Trial Locations

Locations (1)

The second affiliated hospital of Chongqing medical university; 🇨🇳 Chongqing, China