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NCT06118034
Effect of Colchicine on Perioperative Anti-inflammatory Organ Injury in Cardiac Surgery
Phase 3 trial testing Colchicine 0.5 MG in Inflammatory Response in 768 participants. Currently enrolling.
31 August 2026
Quick facts
| Lead sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 768 |
| Start date | 28 January 2024 |
| Primary completion | 31 August 2026 |
| Estimated completion | 30 December 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- Colchicine 0.5 MG — full drug profile →
- Placebo
Conditions studied
- Inflammatory Response — all drugs for Inflammatory Response →
- Cardiac Disease — all drugs for Cardiac Disease →
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Who can join
Adults 50 to 80, any sex, with Inflammatory Response or Cardiac Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Anti-inflammatory effect of colchicine on organ damage during the perioperative period of cardiac surgery: a study protocol for a multicentre, randomised, double-blind, placebo-controlled clinical trial.
Li X, Luo Y, Cai X, Lv Z, et al · · 2024 · PMID 39266309 · DOI 10.1136/bmjopen-2024-084368
Verify or expand the search:
- PubMed search for NCT06118034
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06118034 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Last refreshed: 17 November 2025
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