Cardiac Disease Clinical Trial
Official title:
Effect of Colchicine on Perioperative Anti-inflammatory Organ Injury in Cardiac Surgery : a Multi-center, Randomized, Controlled, Double-blind Clinical Trial
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.
Status | Recruiting |
Enrollment | 768 |
Est. completion date | December 30, 2026 |
Est. primary completion date | August 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Age between 18 and 80 years, any gender; 2. Patients undergoing elective cardiac surgery; 3. Signed informed consent. Exclusion Criteria: 1. Patients undergoing emergency surgery; 2. Patients undergoing deep hypothermic circulatory arrest surgery; 3. Predicted mortality rate exceeding 3% according to the European System for 4. Cardiac Operative Risk Evaluation (EuroSCORE II); 5. Patients undergoing off-pump coronary artery bypass grafting (CABG) surgery; 6. Patients undergoing left or right ventricular outflow tract surgery; 7. Patients undergoing complex congenital heart disease correction surgery; 8. Patients with an expected extracorporeal circulation time exceeding 180 minutes or 9. Anticipated aortic cross-clamp time exceeding 120 minutes; 10. Patients with an expected postoperative extubation time exceeding 24 hours; 11. Patients with long-term fasting or those unable to self-feed; 12. Patients with a history of malignant tumors; 13. Patients with unstable preoperative vital signs requiring ECMO or IABP assistance; 14. Patients with a history of previous cardiac surgery; 15. Patients with preoperative gastrointestinal symptoms; 16. Patients on long-term hepatoprotective medication; 17. Patients with impaired liver and kidney function (Child-Pugh class B or C); 18. Estimated glomerular filtration rate <35 mL/min/1.73 m2); 19. Abnormal baseline inflammatory markers [interleukin-6 (IL6) >10 pg/mL, procalcitonin (PCT) >0.5 ng/mL, C-reactive protein (CRP) >10 mg/L]; 20. Patients diagnosed with infectious diseases, inflammatory immune disorders, infectious diseases, or malignant diseases; 21. Patients who have received immunosuppressive or anti-inflammatory treatments; 22. Patients allergic to or intolerant of colchicine; 23. Breastfeeding or pregnant women; 24. Other circumstances in which the investigator deems the patient unsuitable for participation in this study. Patients with a history of dialysis before surgery; Patients with a history of atrial fibrillation before surgery |
Country | Name | City | State |
---|---|---|---|
China | Dong-Jin Wang | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | First Affiliated Hospital of Harbin Medical University, First Affiliated Hospital of Zhejiang University, Jinan Central Hospital, Renji Hospital Affiliated to The Shanghai Jiao Tong University Medical School, The First People's Hospital of Changzhou, Xinhua hospital of ILi in Kazakhstan automomous district, Yangzhou University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The incidence of postoperative inflammatory diseases | Postoperative inflammatory diseases include: postoperative atrial fibrillation; perioperative myocardial injury; acute respiratory distress syndrome; Post-pericardial syndrome | postoperative 28 days | |
Secondary | Oxygenation index | SpO2 /FIO2 | postoperative day 1, 3, 5 and 7 | |
Secondary | Inflammatory index | WBC[×109/L], Neutrophil[NEU,%], Interleukin(IL)-1ß[pg/mL], IL-6[pg/mL], IL-8[pg/mL], TNF-a[pg/mL], CRP[mg/L], PCT[ng/mL], neutrophil elastase[NE,ng/mL] and myeloperoxidase[MPO, ng/ml] | postoperative day 1, 3, 5 and 7 | |
Secondary | Myocardial injury marker | myoglobin[Myo, ng/ml], CK-MB[ng/ml], hs-cTnT[ng/ml] | postoperative day 1, 3, 5 and 7 | |
Secondary | 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 | postoperative day 1, 3, 5 and 7 | |
Secondary | Murray socre | 0 score - Indicates no lung injury; Less than 2.5 score - Indicates mild to moderate lung injury; More than 2.5 score - Indicates presence of severe ARDS. rs: respiratory rate, oxygenation, temperature, blood pressure, heart rate, and mental status | postoperative day 1, 3, 5 and 7 | |
Secondary | Liver and kidney function | ALT[U/L], AST[U/L], BUN[mmol/L], creatinine[µmol/L], eGFR[mL/min/1.73m2], total bilirubin[mg/dL] | postoperative day 1, 3, 5 and 7 | |
Secondary | DVMV | Duration of mechanical ventilation | postoperative 28 days | |
Secondary | ICU time | Time to stay in the intensive care unit | postoperative 28 days | |
Secondary | In-hospital time | All time during hospitalization | postoperative 28 days | |
Secondary | 30-day all-cause mortality | Proportion of deaths caused by various reasons within a certain period of time (30 days) compared to the total number of people in a certain group | postoperative 30 days | |
Secondary | 90-day all-cause mortality | Proportion of deaths caused by various reasons within a certain period of time (90 days) compared to the total number of people in a certain group | postoperative 90 days | |
Secondary | Incidence of gastrointestinal reactions | Adverse reactions related to colchicine | postoperative 7 days |
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