drugset / Trial / NCT06118034
Effect of Colchicine on Perioperative Anti-inflammatory Organ Injury in Cardiac Surgery
Phase 3
Recruiting
768 enrolled
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Affiliated Hospital of Nantong University · collabFirst Affiliated Hospital of Harbin Medical University · collabFirst Affiliated Hospital of Zhejiang University · collabHuai'an First People's Hospital · collabJinan Central Hospital · collabShandong Provincial Hospital · collabThe First Affilated Hospital of the Medical College, Shihezi University · collabThe First People's Hospital of Changzhou · collabXinhua hospital of ILi in Kazakhstan automomous district · collabYangzhou University · collab
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2024-01-28
- Primary completion
- 2026-08-31
- Completion
- 2026-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Colchicine | Small molecule | 0.5 mg | Oral |