Colchicine's effect on inflammation during cardiac surgery

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

This study is testing if colchicine can help reduce inflammation and improve recovery for people aged 50 to 80 who are having heart surgery.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 768 (estimated)
• Ages: 50 Years to 80 Years
• Sex: All
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Academic / other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06118034 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, controlled, double-blind trial investigates the impact of colchicine on inflammatory organ injury in patients undergoing cardiac surgery. A total of 768 patients aged 50 to 80 will be enrolled and randomly assigned to receive either colchicine or a placebo before and after surgery. The study will monitor various clinical indicators, including inflammatory markers and organ function, to assess the efficacy of colchicine in reducing perioperative complications. The trial aims to provide insights into the role of colchicine in managing inflammation during cardiac procedures.

Who should consider this trial

Good fit: Ideal candidates are patients aged 50 to 80 scheduled for elective cardiac surgery.

Not a fit: Patients undergoing emergency surgeries or those with high predicted mortality risks may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved outcomes and reduced organ injury for patients undergoing cardiac surgery.

How similar studies have performed: Previous studies have shown promise in using colchicine for inflammatory conditions, but this specific application in cardiac surgery is novel.

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.

Where this trial is running

Nanjing, Jiangsu

• Dong-Jin Wang — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Principal investigator: DongJin Wang, M.D — The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Study coordinator: Tuo Pan, MD

Conditions Inflammatory Response; Cardiac Disease