Cardiac Surgery and Postoperative Organ Dysfunction

NCT05529212 | Unknown

• 1 other identifier: Organ Dysfunction during CPB
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Complications

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Incidence of postoperative arrhythmia events

  from the ending of surgery to 72 hours after surgery

Interventions

ischemic reperfusion injury PROCEDURE

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.

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead
• Second Affiliated Hospital of Third Military Medical University: collaborator

Study Sites (1)

The second affiliated hospital of Chongqing medical university

Chongqing, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood and tissue samples be collected for biochemical testing.

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• He Huang, MD

  Chongqing Medical University, the second affiliated hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiao Guo, MD

CONTACT

13637870013; guoqiao@cqmu.edu.cn

Dagang Wang, MD

CONTACT

+86 023 63693014; kuanrenlunli@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 6, 2022
• Study Start: September 16, 2022
• Primary Completion: September 30, 2023
• Study Completion: November 30, 2023
• Last Updated: September 6, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Within five years

Locations

CN (1)