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Can a common gout pill protect the heart and lungs during surgery?

NCT ID NCT06118034

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 768 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

50 to 80 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Dong-Jin Wang

    RECRUITING

    Nanjing, Jiangsu, 210008, China

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