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

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 17, 2025 (before its estimated August 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Re-verified, no change to tracked fieldsv5
  2. Collaborators: 7 to 10v4 See this version in full on ClinicalTrials.gov ↗
  3. Primary endpoints: 1 to 4 Eligibility criteria expanded, about 13 words · Secondary endpoints: 12 to 16v3 Show 2 more changesShow less
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: 12 to 16

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Jan 1, 2024 to Jan 28, 2024v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Jan 1, 2024 to Jan 28, 2024
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06118034
Lead Sponsor The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborators: First Affiliated Hospital of Zhejiang University, Jinan Central Hospital, The First People's Hospital of Changzhou, Xinhua hospital of ILi in Kazakhstan automomous district, First Affiliated Hospital of Harbin Medical University, Yangzhou University, Shandong Provincial Hospital, Huai'an First People's Hospital, The First Affilated Hospital of the Medical College, Shihezi University, Affiliated Hospital of Nantong University
Conditions Inflammatory Response, Cardiac Disease
Enrollment 768 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov