Effect of Colchicine on Perioperative Anti-inflammatory Organ Injury in Cardiac Surgery
- Conditions
- Inflammatory ResponseCardiac Disease
- Interventions
- Drug: Placebo
- Registration Number
- NCT06118034
- Lead Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 768
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group (colchicine group) Colchicine 0.5 MG 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. Control group Placebo 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.
- Primary Outcome Measures
Name Time Method Number of Participants with POAF postoperative 10 days POAF: Onset of new atrial fibrillation in patients within 10 days post-surgery.
Number of Participants with PMI postoperative 10 days 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 postoperative 10 days ARDS: Acute Respiratory Distress Syndrome
Number of Participants with PPS postoperative 10 days PPS: post-pericardiotomy syndrome
- Secondary Outcome Measures
Name Time Method Myocardial injury marker postoperative day 1, 3, 5 and 7 myoglobin\[Myo, ng/ml\], CK-MB\[ng/ml\], hs-cTnT\[ng/ml\]
blood transfusion Surgical day blood transfusion volume(ml)
Rate of exudates on chest radiograph postoperative 14 days Chest radiograph on postoperative days 1, 2, and 3, and chest CT within 14 days after surgery
Oxygenation index postoperative day 1, 3, 5 and 7 SpO2 /FIO2
Inflammatory index postoperative day 1, 3, 5 and 7 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\[MPO, ng/ml\]
Acute physiology and chronic health evaluation(APACHE II) socre postoperative day 1, 3, 5 and 7 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
Murray lung injury score postoperative day 1, 3, 5 and 7 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
Liver and kidney function postoperative day 1, 3, 5 and 7 ALT\[U/L\], AST\[U/L\], BUN\[mmol/L\], creatinine\[μmol/L\], eGFR\[mL/min/1.73m2\], total bilirubin\[mg/dL\]
DVMV postoperative 28 days Duration of mechanical ventilation
ICU time postoperative 28 days Time to stay in the intensive care unit
In-hospital time postoperative 28 days All time during hospitalization
30-day all-cause mortality postoperative 30 days 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
90-day all-cause mortality postoperative 90 days 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
Incidence of gastrointestinal reactions postoperative 7 days Adverse reactions related to colchicine
Surgical data Surgical day aortic cross-clamp time (min)
Trial Locations
- Locations (1)
Dong-Jin Wang
🇨🇳Nanjing, Jiangsu, China