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

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.

Conditions

• Inflammatory Response
• Cardiac Disease

Interventions

DRUG

Colchicine 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.

DRUG

Placebo

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.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University

  collaborator OTHER

• Jinan Central Hospital

  collaborator OTHER

• The First People's Hospital of Changzhou

  collaborator OTHER

• Xinhua hospital of ILi in Kazakhstan automomous district

  collaborator UNKNOWN

• First Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• The Affiliated Hospital of Yangzhou University

  collaborator UNKNOWN

• Shandong Provincial Hospital

  collaborator OTHER_GOV

• The First People's Hospital of Huai'an

  collaborator UNKNOWN

• The First Affiliated Hospital of Shihezi University Medical College

  collaborator UNKNOWN

• Affiliated Hospital of Nantong University

  collaborator OTHER

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  lead OTHER

Principal Investigators

• Tuo Pan, M.D · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

• DongJin Wang, M.D · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

• DongJin Wang, M.D · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-28

Primary Completion

2026-08-31

Completion

2026-12-30

Countries

• China

Study Locations