Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT06118034
Eligibility Criteria:
Inclusion criteria
1. Aged between 50 and 80 years, male or female;
2. Patients undergoing elective cardiac surgery;
3. Have signed the informed consent form (ICF).
Exclusion criteria
1. Patients undergoing emergency surgery;
2. Patients undergoing deep hypothermic circulatory arrest surgery;
3. Preoperative predicted mortality \>3% according to European System for Cardiac Operative Risk Evaluation II (EuroSCORE II);
4. Patients undergoing off-pump coronary artery bypass grafting (off-pump CABG) surgery;
5. Patients undergoing left or right ventricular outflow tract obstruction surgery;
6. Patients undergoing complex corrective surgery for congenital heart disease;
7. Patients with an expected CPB exceeding 180 minutes or an anticipated aortic cross-clamp time exceeding 120 minutes;
8. Patients expected to have a postoperative endotracheal tube removal time exceeding 24 hours;
9. Patients with prolonged fasting or inability to self-feed;
10. A history of malignant tumor;
11. Patients with unstable preoperative vital signs requiring intra-aortic balloon pump (IABP), extracorporeal membrane oxygenation (ECMO)assistance, or endotracheal tube-assisted ventilation;
12. A history of cardiac surgery;
13. Patients with preoperative gastrointestinal symptoms, such as nausea, vomiting and diarrhea;
14. Patients with a history of dialysis before surgery;
15. Patients with a history of atrial fibrillation before surgery;
16. Patients on long-term hepatorenal protective medications;
17. Patients with hepatic and renal insufficiency (Child-Pugh class B or C, estimated glomerular filtration rate \<35 mL/min/1.73 m2);
18. Patients with abnormal baseline inflammatory markers \[interleukin-6 (IL6) \>10 pg/mL, procalcitonin (PCT) \>0.5 ng/mL, C reactive protein (CRP) \>10 mg/L\];
19. Patients diagnosed with infectious diseases, inflammatory immune diseases, or tumor;
20. Patients who have received immunosuppressive or anti-inflammatory treatment;
21. Patients allergic or intolerant to colchicine;
22. Breastfeeding or pregnant women;
23. Other situations deemed inappropriate for participation in the study by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
80 Years
Study:
NCT06118034
Study Brief:
Protocol Section:
NCT06118034