Can a common gout pill protect the heart and lungs during surgery?
NCT ID NCT06118034
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether the anti-inflammatory drug colchicine can reduce organ damage after heart surgery. About 768 adults aged 50-80 having planned heart surgery will take either colchicine or a placebo before and after their operation. Researchers will track complications like atrial fibrillation, heart attack, and lung injury.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- colchicine
- What this could lead to
- If it works, this could reduce serious complications like atrial fibrillation, heart attack, and lung injury after heart surgery.
- What could go wrong
- This is a phase 3 trial, but colchicine may cause gastrointestinal side effects and may not reduce complications as hoped. Results may not apply to all heart surgery patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 768 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria 1. Aged between 50 and 80 years, male or female; 2. Patients undergoing elective cardiac surgery; 3. Have signed the informed consent form (ICF). Exclusion criteria 1. Patients undergoing emergency surgery; 2. Patients undergoing deep hypothermic circulatory arrest surgery; 3. Preoperative predicted mortality \>3% according to European System for Cardiac Operative Risk Evaluation II (EuroSCORE II); 4. Patients undergoing off-pump coronary artery bypass grafting (off-pump CABG) surgery; 5. Patients undergoing left or right ventricular outflow tract obstruction surgery; 6. Patients undergoing complex corrective surgery for congenital heart disease; 7. Patients with an expected CPB exceeding 180 minutes or an anticipated aortic cross-clamp time exceeding 120 minutes; 8. Patients expected to have a postoperative endotracheal tube removal time exceeding 24 hours; 9. Patients with prolonged fasting or inability to self-feed; 10. A history of malignant tumor; 11. Patients with unstable preoperative vital signs requiring intra-aortic balloon pump (IABP), extracorporeal membrane oxygenation (ECMO)assistance, or endotracheal tube-assisted ventilation; 12. A history of cardiac surgery; 13. Patients with preoperative gastrointestinal symptoms, such as nausea, vomiting and diarrhea; 14. Patients with a history of dialysis before surgery; 15. Patients with a history of atrial fibrillation before surgery; 16. Patients on long-term hepatorenal protective medications; 17. Patients with hepatic and renal insufficiency (Child-Pugh class B or C, estimated glomerular filtration rate \<35 mL/min/1.73 m2); 18. Patients with abnormal baseline inflammatory markers \[interleukin-6 (IL6) \>10 pg/mL, procalcitonin (PCT) \>0.5 ng/mL, C reactive protein (CRP) \>10 mg/L\]; 19. Patients diagnosed with infectious diseases, inflammatory immune diseases, or tumor; 20. Patients who have received immunosuppressive or anti-inflammatory treatment; 21. Patients allergic or intolerant to colchicine; 22. Breastfeeding or pregnant women; 23. Other situations deemed inappropriate for participation in the study by the investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Dong-Jin Wang
RECRUITINGNanjing, Jiangsu, 210008, China
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