RecruitingPhase 3NCT06118034

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

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Enrollment

768 participants

Start Date

Jan 28, 2024

Study Type

INTERVENTIONAL

Conditions

Inflammatory Response Cardiac Disease

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.

Eligibility

Min Age: 50 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Colchicine 0.5 MG and a drug called Placebo for people with cardiac disease and inflammatory response. The study is currently recruiting participants at 1 location. People eligible for this study include aged 50 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGColchicine 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.

DRUGPlacebo

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.