Status:
RECRUITING
Effect of Colchicine on Perioperative Anti-inflammatory Organ Injury in Cardiac Surgery
Lead Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborating Sponsors:
First Affiliated Hospital of Zhejiang University
Jinan Central Hospital
Conditions:
Inflammatory Response
Cardiac Disease
Eligibility:
All Genders
50-80 years
Phase:
PHASE3
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, i...
Detailed Description
This study is a multicenter, randomized, controlled, double-blind, placebo- controlled clinical trial. A total of 768 patients who met the inclusion and exclusion criteria and were scheduled for cardi...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Aged between 50 and 80 years, male or female;
- Patients undergoing elective cardiac surgery;
- Have signed the informed consent form (ICF).
- Exclusion criteria
- Patients undergoing emergency surgery;
- Patients undergoing deep hypothermic circulatory arrest surgery;
- Preoperative predicted mortality \>3% according to European System for Cardiac Operative Risk Evaluation II (EuroSCORE II);
- Patients undergoing off-pump coronary artery bypass grafting (off-pump CABG) surgery;
- Patients undergoing left or right ventricular outflow tract obstruction surgery;
- Patients undergoing complex corrective surgery for congenital heart disease;
- Patients with an expected CPB exceeding 180 minutes or an anticipated aortic cross-clamp time exceeding 120 minutes;
- Patients expected to have a postoperative endotracheal tube removal time exceeding 24 hours;
- Patients with prolonged fasting or inability to self-feed;
- A history of malignant tumor;
- Patients with unstable preoperative vital signs requiring intra-aortic balloon pump (IABP), extracorporeal membrane oxygenation (ECMO)assistance, or endotracheal tube-assisted ventilation;
- A history of cardiac surgery;
- Patients with preoperative gastrointestinal symptoms, such as nausea, vomiting and diarrhea;
- Patients with a history of dialysis before surgery;
- Patients with a history of atrial fibrillation before surgery;
- Patients on long-term hepatorenal protective medications;
- Patients with hepatic and renal insufficiency (Child-Pugh class B or C, estimated glomerular filtration rate \<35 mL/min/1.73 m2);
- Patients with abnormal baseline inflammatory markers \[interleukin-6 (IL6) \>10 pg/mL, procalcitonin (PCT) \>0.5 ng/mL, C reactive protein (CRP) \>10 mg/L\];
- Patients diagnosed with infectious diseases, inflammatory immune diseases, or tumor;
- Patients who have received immunosuppressive or anti-inflammatory treatment;
- Patients allergic or intolerant to colchicine;
- Breastfeeding or pregnant women;
- Other situations deemed inappropriate for participation in the study by the investigator.
Exclusion
Key Trial Info
Start Date :
January 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
768 Patients enrolled
Trial Details
Trial ID
NCT06118034
Start Date
January 28 2024
End Date
December 30 2026
Last Update
November 17 2025
Active Locations (1)
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1
Dong-Jin Wang
Nanjing, Jiangsu, China, 210008