Effect of Colchicine on Perioperative Anti-inflammatory Organ Injury in Cardiac Surgery : a Multi-center, Randomized, Controlled, Double-blind Clinical Trial

DJ Wang

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.

2024-01-28

2026-08-31

2026-12-30

Recruiting

Early phase I

768

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 768, 'type': 'ESTIMATED'}}

2024-05-21