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

NCT ID: NCT06118034

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 768 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-28
• Study Completion Date: 2026-12-30

Brief 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.

Detailed Description

This study is a multicenter, randomized, controlled, double-blind, placebo- controlled clinical trial. A total of 768 patients who met the inclusion and exclusion criteria and were scheduled for cardiac surgery under cardiopulmonary bypass were enrolled. After signing informed consent, patients were randomly divided into the experimental group and the control group. Patients in the experimental group took 0.5mg of colchicine tablets orally for 3 days before surgery and continued to take 0.5mg daily for 10 days after tracheal extubation. Patients in the control group received an equivalent amount of starch placebo tablets, administered at the same times and in the same doses as the experimental group, during the colchicine/placebo treatment period, without affecting the patients' standard treatment protocols.

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. The study aims to investigate the impact of colchicine on the levels of inflammatory factors and prognosis in patients undergoing cardiac vascular surgery and to observe the potential organ damage to the heart, lungs, liver, kidneys, and the occurrence of adverse events such as leukopenia and thrombocytopenia. This is done to assess the safety of colchicine use in cardiac surgery patients.

Conditions

Inflammatory Response; Cardiac Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Control group

The control group take 0.5mg of placebo tablets orally for 3 days before surgery, and continue to take 0.5mg every other day (qod) for 10 days after tracheal extubation.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Take 0.5mg of starch tablets orally for 3 days before surgery, and continued to take 0.5mg every other day (qod) for 10 days after tracheal extubation.

Experimental group (colchicine group)

The experimental group take 0.5mg of colchicine tablets orally for 3 days before surgery, and continue to take 0.5mg every other day (qod) for 10 days after tracheal extubation.

Group Type: EXPERIMENTAL

Colchicine 0.5 MG

Intervention Type: DRUG

Take 0.5mg of colchicine tablets orally for 3 days before surgery, and continued to take 0.5mg every other day (qod) for 10 days after tracheal extubation.

Interventions

Colchicine 0.5 MG

Take 0.5mg of colchicine tablets orally for 3 days before surgery, and continued to take 0.5mg every other day (qod) for 10 days after tracheal extubation.

Intervention Type: DRUG

Placebo

Take 0.5mg of starch tablets orally for 3 days before surgery, and continued to take 0.5mg every other day (qod) for 10 days after tracheal extubation.

Intervention Type: DRUG

Other Intervention Names

Routine cardiovascular surgery and peri-operative management; Routine cardiovascular surgery and peri-operative management

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: collaborator

Jinan Central Hospital

OTHER

Sponsor Role: collaborator

The First People's Hospital of Changzhou

OTHER

Sponsor Role: collaborator

Xinhua hospital of ILi in Kazakhstan automomous district

UNKNOWN

Sponsor Role: collaborator

First Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role: collaborator

The Affiliated Hospital of Yangzhou University

UNKNOWN

Sponsor Role: collaborator

Shandong Provincial Hospital

OTHER_GOV

Sponsor Role: collaborator

The First People's Hospital of Huai'an

UNKNOWN

Sponsor Role: collaborator

The First Affiliated Hospital of Shihezi University Medical College

UNKNOWN

Sponsor Role: collaborator

Affiliated Hospital of Nantong University

OTHER

Sponsor Role: collaborator

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tuo Pan, M.D

Role: STUDY_DIRECTOR

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

DongJin Wang, M.D

Role: STUDY_CHAIR

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

DongJin Wang, M.D

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Locations

Dong-Jin Wang

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Tuo Pan, MD

Role: CONTACT

pan_tuo@126.com

+8615205160210

Dongjin Wang, MD

Role: CONTACT

Dongjin_wang@126.com

Facility Contacts

Tuo Pan, MD

Role: primary

pan_tuo@126.com

+8615205160210

References

Li X, Luo Y, Cai X, Lv Z, Kong Y, Guo Q, Zhu J, Pan T, Wang D. 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. BMJ Open. 2024 Sep 12;14(9):e084368. doi: 10.1136/bmjopen-2024-084368.

Reference Type: DERIVED

PMID: 39266309 (View on PubMed)

Other Identifiers

2023-LCYJ-ZD-03

Identifier Type: -

Identifier Source: org_study_id