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| Name | Class |
|---|---|
| First Affiliated Hospital of Zhejiang University | OTHER |
| Jinan Central Hospital | OTHER |
| The First People's Hospital of Changzhou | OTHER |
| Xinhua hospital of ILi in Kazakhstan automomous district |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine 0.5 MG | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with POAF | POAF: Onset of new atrial fibrillation in patients within 10 days post-surgery. | postoperative 10 days |
| 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. | postoperative 10 days |
| Number of Participants with ARDS | ARDS: Acute Respiratory Distress Syndrome | postoperative 10 days |
| Number of Participants with PPS | PPS: post-pericardiotomy syndrome | postoperative 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygenation index | SpO2 /FIO2 | postoperative day 1, 3, 5 and 7 |
| 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] |
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Inclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tuo Pan, MD | Contact | +8615205160210 | pan_tuo@126.com | |
| Dongjin Wang, MD | Contact | Dongjin_wang@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Tuo Pan, M.D | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Study Director |
| DongJin Wang, M.D | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dong-Jin Wang | Recruiting | Nanjing | Jiangsu | 210008 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39266309 | Derived | Li X, Luo Y, Cai X, Lv Z, Kong Y, Guo Q, Zhu J, Pan T, Wang D. Anti-inflammatory effect of colchicine on organ damage during the perioperative period of cardiac surgery: a study protocol for a multicentre, randomised, double-blind, placebo-controlled clinical trial. BMJ Open. 2024 Sep 12;14(9):e084368. doi: 10.1136/bmjopen-2024-084368. |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| UNKNOWN |
| First Affiliated Hospital of Harbin Medical University | OTHER |
| Yangzhou University | OTHER |
| Shandong Provincial Hospital | OTHER_GOV |
| Huai'an First People's Hospital | OTHER |
| The First Affilated Hospital of the Medical College, Shihezi University | OTHER |
| Affiliated Hospital of Nantong University | OTHER |
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| Placebo | Drug | 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. |
|
|
| postoperative day 1, 3, 5 and 7 |
| Myocardial injury marker | myoglobin[Myo, ng/ml], CK-MB[ng/ml], hs-cTnT[ng/ml] | postoperative day 1, 3, 5 and 7 |
| 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 |
| Murray lung injury score | 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 |
| 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 |
| DVMV | Duration of mechanical ventilation | postoperative 28 days |
| ICU time | Time to stay in the intensive care unit | postoperative 28 days |
| In-hospital time | All time during hospitalization | postoperative 28 days |
| 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 |
| 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 |
| Incidence of gastrointestinal reactions | Adverse reactions related to colchicine | postoperative 7 days |
| Surgical data | cardiopulmonary bypass time (min) | Surgical day |
| Surgical data | aortic cross-clamp time (min) | Surgical day |
| blood transfusion | blood transfusion volume(ml) | Surgical day |
| Rate of exudates on chest radiograph | Chest radiograph on postoperative days 1, 2, and 3, and chest CT within 14 days after surgery | postoperative 14 days |
| DongJin Wang, M.D | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Principal Investigator |