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.
Aged between 50 and 80 years, male or female;
Patients undergoing elective cardiac surgery;
Have signed the informed consent form (ICF).
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;
Parallel
Colchicine 0.5 MG
DrugTake 0.5mg of colchicine tablets orally for 3 days before surgery, and continued to take 0.5mg every other day (qod) for 10 days after tracheal extubation.
Placebo
DrugTake 0.5mg of starch tablets orally for 3 days before surgery, and continued to take 0.5mg every other day (qod) for 10 days after tracheal extubation.
Number of Participants with POAF
POAF: Onset of new atrial fibrillation in patients within 10 days post-surgery.
Number of Participants with PMI
PMI: Patient's high-sensitivity cardiac troponin T (hs-cTnT) exceeds 0.8 ng/L on the first day after surgery, and there is an increase of 10% or more on the second day compared to the first day postoperatively.
Number of Participants with ARDS
ARDS: Acute Respiratory Distress Syndrome
Number of Participants with PPS
PPS: post-pericardiotomy syndrome
Oxygenation index
SpO2 /FIO2
Inflammatory index
WBC\[×109/L\], Neutrophil\[NEU,%\], Interleukin(IL)-1β\[pg/mL\], IL-6\[pg/mL\], IL-8\[pg/mL\], TNF-α\[pg/mL\], CRP\[mg/L\], PCT\[ng/mL\], neutrophil elastase\[NE,ng/mL\] and myeloperoxidase\[MPO, ng/ml\]
Myocardial injury marker
myoglobin\[Myo, ng/ml\], CK-MB\[ng/ml\], hs-cTnT\[ng/ml\]
Acute physiology and chronic health evaluation(APACHE II) socre
Interpretation of APACHE II : minimum 0 and maximum 71; increasing score is associated with an increasing risk of hospital death. acute physiology score, chronic health status score, and age adjustment score
Click on the lead sponsor to view all of their trials.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Lead sponsor
First Affiliated Hospital of Zhejiang University
Collaborator
Jinan Central Hospital
Collaborator
The First People's Hospital of Changzhou
Collaborator
Xinhua hospital of ILi in Kazakhstan automomous district
Collaborator
First Affiliated Hospital of Harbin Medical University
Collaborator
Yangzhou University
Collaborator
Shandong Provincial Hospital
Collaborator
Huai'an First People's Hospital
Collaborator
The First Affilated Hospital of the Medical College, Shihezi University
Collaborator
Affiliated Hospital of Nantong University
Collaborator
