Effect of Colchicine on Perioperative Anti-inflammatory Organ Injury in Cardiac Surgery

• Status: Recruiting
• Trial end date: 2026-12-30
• Target enrollment: 0
• Participant gender: All

Summary

All patients will be completed collection of demographic data, clinical data, and be observed for inflammatory organ damage, oxygenation index or SpO2/ FIO2, WBC, NEU, interleukin-1β, interleukin-6, interleukin-8 (IL-1β/6/8), tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), procalcitonin (PCT), myoglobin (Myo), creatine kinase-MB (CK-MB), high-sensitivity cardiac troponin T (hs-cTnT), neutrophil elastase (NE), myeloperoxidase (MPO), APACHE II score, alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin, Murray lung injury score, serum creatinine, eGFR, mechanical ventilation time, ICU length of stay, drug-related gastrointestinal reactions, and 30-day and 90-day all-cause mortality, among other indicators.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Collaborators: First Affiliated Hospital of Harbin Medical University; First Affiliated Hospital of Zhejiang University; Jinan Central Hospital; Renji Hospital Affiliated to The Shanghai Jiao Tong University Medical School; The First People's Hospital of Changzhou; Xinhua hospital of ILi in Kazakhstan automomous district; Yangzhou University
• Treatments: Colchicine

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.