← Back to Clinical Trials
Recruiting Phase 3 NCT06118034

NCT06118034 Effect of Colchicine on Perioperative Anti-inflammatory Organ Injury in Cardiac Surgery

◆ AI Clinical Summary
Plain-language summary for patients
Clinical Trial Summary
NCT ID NCT06118034
Status Recruiting
Phase Phase 3
Sponsor The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Condition Inflammatory Response
Study Type INTERVENTIONAL
Enrollment 768 participants
Start Date 2024-01-28
Primary Completion 2026-08-31

Trial Parameters

Condition Inflammatory Response
Sponsor The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 768
Sex ALL
Min Age 50 Years
Max Age 80 Years
Start Date 2024-01-28
Completion 2026-08-31
Interventions
Colchicine 0.5 MGPlacebo

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

Brief 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.

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 w

Related Trials

ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: April 2026  ·  Data Methodology