NCT06118034 Effect of Colchicine on Perioperative Anti-inflammatory Organ Injury in Cardiac Surgery
| 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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 768 participants in total. It began in 2024-01-28 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Contact & Investigator
Tuo Pan, M.D
STUDY DIRECTOR
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Frequently Asked Questions
Who can join the NCT06118034 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 80 Years, studying Inflammatory Response. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06118034 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 768 participants.
Is NCT06118034 currently recruiting?
Yes, NCT06118034 is actively recruiting participants. Contact the research team at pan_tuo@126.com for enrollment information.
Where is the NCT06118034 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT06118034 clinical trial?
NCT06118034 is sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. The principal investigator is Tuo Pan, M.D at The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. The trial plans to enroll 768 participants.