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

Launched by THE AFFILIATED NANJING DRUM TOWER HOSPITAL OF NANJING UNIVERSITY MEDICAL SCHOOL · Nov 1, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how a medication called colchicine might help reduce inflammation and prevent organ damage in patients undergoing heart surgery. Inflammation is the body's response to surgery, and sometimes it can lead to complications. The trial is specifically looking at patients aged 50 to 80 who are scheduled for elective heart surgeries, meaning the surgery is planned in advance rather than being an emergency. To participate, patients need to understand the study and sign a consent form.

If eligible, participants will be monitored closely during and after their surgery. The researchers will collect various health information, such as blood tests and how well the heart and other organs are functioning. They will also keep track of recovery times, any complications, and overall health outcomes for up to 90 days after surgery. It's important to note that certain patients, like those with specific health conditions or those undergoing emergency surgeries, cannot join the study. This trial aims to find out if colchicine can improve recovery and reduce risks for heart surgery patients.

Gender

ALL

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.