[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525153":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":42,"locations":52,"responsibleParty":69,"collaborators":71,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":47,"eligibilityCriteria":100,"healthyVolunteers":96,"sex":101,"minAge":102,"maxAge":103,"enrollmentInfo":104,"targetDuration":47,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":47,"overallStatus":55,"whyStopped":47,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental group (colchicine group)","EXPERIMENTAL","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.",[13],"Drug: Colchicine 0.5 MG",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","PLACEBO_COMPARATOR","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.",[19],"Drug: Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Colchicine 0.5 MG","Take 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.",[9],[27],"Routine cardiovascular surgery and peri-operative management",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Placebo","Take 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.",[15],[27],[34,37,40],{"name":35,"affiliation":5,"role":36},"Tuo Pan, M.D","STUDY_DIRECTOR",{"name":38,"affiliation":5,"role":39},"DongJin Wang, M.D","STUDY_CHAIR",{"name":38,"affiliation":5,"role":41},"PRINCIPAL_INVESTIGATOR",[43,49],{"name":44,"role":45,"phone":46,"phoneExt":47,"email":48},"Tuo Pan, MD","CONTACT","+8615205160210",null,"pan_tuo@126.com",{"name":50,"role":45,"phone":47,"phoneExt":47,"email":51},"Dongjin Wang, MD","Dongjin_wang@126.com",[53],{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Dong-Jin Wang","RECRUITING","Nanjing","Jiangsu","210008","China","CN",{"type":62,"coordinates":63},"Point",[64,65],118.77778,32.06167,{"lat":65,"lon":64},[68],{"name":44,"role":45,"phone":46,"phoneExt":47,"email":48},{"type":70,"investigatorFullName":47,"investigatorTitle":47,"investigatorAffiliation":47,"oldNameTitle":47,"oldOrganization":47},"SPONSOR",[72,74,76,78,81,83,85,88,90,92],{"name":73,"class":6},"First Affiliated Hospital of Zhejiang University",{"name":75,"class":6},"Jinan Central Hospital",{"name":77,"class":6},"The First People's Hospital of Changzhou",{"name":79,"class":80},"Xinhua hospital of ILi in Kazakhstan automomous district","UNKNOWN",{"name":82,"class":6},"First Affiliated Hospital of Harbin Medical University",{"name":84,"class":6},"Yangzhou University",{"name":86,"class":87},"Shandong Provincial Hospital","OTHER_GOV",{"name":89,"class":6},"Huai'an First People's Hospital",{"name":91,"class":6},"The First Affilated Hospital of the Medical College, Shihezi University",{"name":93,"class":6},"Affiliated Hospital of Nantong University","100525153","phase-3-effect-of-colchicine-on-perioperative-anti-inflammatory-organ-injury-in-cardiac-surgery-100525153",false,"NCT06118034","Effect of Colchicine on Perioperative Anti-inflammatory Organ Injury in Cardiac Surgery","Effect of Colchicine on Perioperative Anti-inflammatory Organ Injury in Cardiac Surgery : a Multi-center, Randomized, Controlled, Double-blind Clinical Trial","Inclusion criteria\n\n1. Aged between 50 and 80 years, male or female;\n2. Patients undergoing elective cardiac surgery;\n3. Have signed the informed consent form (ICF).\n\nExclusion criteria\n\n1. Patients undergoing emergency surgery;\n2. Patients undergoing deep hypothermic circulatory arrest surgery;\n3. Preoperative predicted mortality \\>3% according to European System for Cardiac Operative Risk Evaluation II (EuroSCORE II);\n4. Patients undergoing off-pump coronary artery bypass grafting (off-pump CABG) surgery;\n5. Patients undergoing left or right ventricular outflow tract obstruction surgery;\n6. Patients undergoing complex corrective surgery for congenital heart disease;\n7. Patients with an expected CPB exceeding 180 minutes or an anticipated aortic cross-clamp time exceeding 120 minutes;\n8. Patients expected to have a postoperative endotracheal tube removal time exceeding 24 hours;\n9. Patients with prolonged fasting or inability to self-feed;\n10. A history of malignant tumor;\n11. Patients with unstable preoperative vital signs requiring intra-aortic balloon pump (IABP), extracorporeal membrane oxygenation (ECMO)assistance, or endotracheal tube-assisted ventilation;\n12. A history of cardiac surgery;\n13. Patients with preoperative gastrointestinal symptoms, such as nausea, vomiting and diarrhea;\n14. Patients with a history of dialysis before surgery;\n15. Patients with a history of atrial fibrillation before surgery;\n16. Patients on long-term hepatorenal protective medications;\n17. Patients with hepatic and renal insufficiency (Child-Pugh class B or C, estimated glomerular filtration rate \\\u003C35 mL\u002Fmin\u002F1.73 m2);\n18. Patients with abnormal baseline inflammatory markers \\[interleukin-6 (IL6) \\>10 pg\u002FmL, procalcitonin (PCT) \\>0.5 ng\u002FmL, C reactive protein (CRP) \\>10 mg\u002FL\\];\n19. Patients diagnosed with infectious diseases, inflammatory immune diseases, or tumor;\n20. Patients who have received immunosuppressive or anti-inflammatory treatment;\n21. Patients allergic or intolerant to colchicine;\n22. Breastfeeding or pregnant women;\n23. Other situations deemed inappropriate for participation in the study by the investigator.","ALL","50 Years","80 Years",{"count":105,"type":106},768,"ESTIMATED","INTERVENTIONAL",[109],"PHASE3","All patients will be completed collection of demographic data, clinical data, and be observed for inflammatory organ damage, oxygenation index or SpO2\u002F FIO2, WBC, NEU, interleukin-1β, interleukin-6, interleukin-8 (IL-1β\u002F6\u002F8), 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.",[112,113],"Inflammatory Response","Cardiac Disease","2025-11-13",{"date":116,"type":117},"2025-11-17","ACTUAL",{"date":119,"type":117},"2024-01-28",{"date":121,"type":106},"2026-12-30",{"name":5,"class":6},1]