Skip to content

The effect of colchicine on anti-inflammatory organ damage during perioperative cardiac surgery

The effect of colchicine on anti-inflammatory organ damage during perioperative cardiac surgery: a multicenter, randomized controlled, double-blind clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096988
Enrollment
Unknown
Registered
2025-02-10
Start date
2024-01-29
Completion date
Unknown
Last updated
2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular diseases requiring cardiac surgery

Interventions

experimental group:Oral colchicine tablets
placebo group:starch flakes

Sponsors

Drum Tower Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Age between 18 and 80 years, any gender; 2.Patients undergoing elective cardiac surgery; 3.Signed informed consent;

Exclusion criteria

Exclusion criteria: 1.Patients undergoing emergency surgery; 2.Patients undergoing deep hypothermic circulatory arrest (DHCA) surgery; 3.Predicted mortality rate according to the European System for Cardiac Operative Risk Evaluation II (EuroSCORE II) > 3%; 4.Patients undergoing off-pump coronary artery bypass grafting (off-pump CABG) surgery; 5.Patients undergoing left or right ventricular outflow tract (LVOTO/RVOTO) repair surgery; 6.Patients undergoing complex congenital heart defect correction surgery; 7.Patients with an expected extracorporeal circulation (ECC) time exceeding 180 minutes or an anticipated aortic cross-clamp time exceeding 120 minutes; 8.Patients with an expected postoperative endotracheal tube removal time exceeding 24 hours; 9.Patients with long-term fasting or inability to self-feed; 10.Patients with a history of malignancy; 11.Patients with unstable preoperative vital signs requiring extracorporeal membrane oxygenation (ECMO) or intra-aortic balloon pump (IABP) assistance; 12.Patients with a history of previous cardiac surgery; 13.Patients with preoperative gastrointestinal symptoms; 14.Patients with a history of dialysis; 15.Patients with a history of atrial fibrillation (AF); 16.Patients on long-term hepatoprotective medication; 17.Patients with hepatic and renal dysfunction (Child-Pugh class B or C, estimated glomerular filtration rate 10 pg/mL, Procalcitonin (PCT) > 0.5 ng/mL, C-reactive protein (CRP) > 10 mg/L]; 19.Patients diagnosed with infectious diseases, inflammatory immune disorders, infectious diseases, or neoplastic diseases. 20. Patients previously treated with immunosuppressive or anti-inflammatory therapies; 20.Patients with an allergy or intolerance to colchicine; 21.Breastfeeding or pregnant women; 22.Other situations deemed inappropriate for participation in this study by the investigators;

Design outcomes

Primary

MeasureTime frame
The incidence of postoperative inflammatory diseases, including postoperative atrial fibrillation, a;

Secondary

MeasureTime frame
Oxygenation index;Inflammatory index;Myocardial injury marker;Acute physiology and chronic health evaluation(APACHE II) socre;Murray lung injury score;Liver and kidney function;Duration of mechanical ventilation;ICU time;30-day all-cause mortality;90-day all-cause mortality;Incidence of gastrointestinal reactions;cardiopulmonary bypass time (min)aortic cross-clamp time (min);blood transfusion;Rate of exudates on chest radiograph;In-hospital time;

Countries

China

Contacts

Public ContactWang Dongjin

Drum Tower Hospital

gldjw@163.com+86 25 89683827

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026