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

Nanjing University

Status and phase: Enrolling; Phase 3

Conditions: Cardiac Disease; Inflammatory Response

Treatments: Drug: Placebo; Drug: Colchicine 0.5 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT06118034

DJ Wang

Details and patient eligibility

About

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.

Full 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 cardiac surgery under cardiopulmonary bypass were enrolled. After signing informed consent, patients were randomly divided into the experimental group and the control group. Patients in the experimental group took 0.5mg of colchicine tablets orally for 3 days before surgery and continued to take 0.5mg daily for 10 days after tracheal extubation. Patients in the control group received an equivalent amount of starch placebo tablets, administered at the same times and in the same doses as the experimental group, during the colchicine/placebo treatment period, without affecting the patients' standard treatment protocols.

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. The study aims to investigate the impact of colchicine on the levels of inflammatory factors and prognosis in patients undergoing cardiac vascular surgery and to observe the potential organ damage to the heart, lungs, liver, kidneys, and the occurrence of adverse events such as leukopenia and thrombocytopenia. This is done to assess the safety of colchicine use in cardiac surgery patients.

Enrollment: 768 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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768 participants in 2 patient groups, including a placebo group

Experimental group (colchicine group)

Experimental group

Description:

The experimental group take 0.5mg of colchicine tablets orally for 3 days before surgery, and continue to take 0.5mg every other day (qod) for 10 days after tracheal extubation.

Treatment:

Drug: Colchicine 0.5 MG

Control group

Placebo Comparator group

Description:

The control group take 0.5mg of placebo tablets orally for 3 days before surgery, and continue to take 0.5mg every other day (qod) for 10 days after tracheal extubation.

Treatment:

Drug: Placebo