Effect of Colchicine on Perioperative Anti-inflammatory Organ Injury in Cardiac Surgery

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50-80
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

About this 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.

Eligibility criteria

Qualifiers

Aged between 50 and 80 years, male or female;

Patients undergoing elective cardiac surgery;

Have signed the informed consent form (ICF).

Disqualifiers

Patients undergoing emergency surgery;

Patients undergoing deep hypothermic circulatory arrest surgery;

Preoperative predicted mortality >3% according to European System for Cardiac Operative Risk Evaluation II (EuroSCORE II);

Patients undergoing off-pump coronary artery bypass grafting (off-pump CABG) surgery;

Trial design

Treatments tested in this trial

  • Colchicine 0.5 MG
  • Placebo

Treatment groups

768 Participants
are divided into 2 treatment groups

Sponsors and collaborators

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Lead sponsor

First Affiliated Hospital of Zhejiang University

Collaborator

Jinan Central Hospital

Collaborator

The First People's Hospital of Changzhou

Collaborator

Xinhua hospital of ILi in Kazakhstan automomous district

Collaborator

First Affiliated Hospital of Harbin Medical University

Collaborator

Yangzhou University

Collaborator

Shandong Provincial Hospital

Collaborator

Huai'an First People's Hospital

Collaborator

The First Affilated Hospital of the Medical College, Shihezi University

Collaborator

Affiliated Hospital of Nantong University

Collaborator