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Evaluation of Low-Dose colchicine in patients with cardiopulmonary bypass

Evaluation of Low-Dose colchicine in patients with cardiopulmonary bypass

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040129
Enrollment
Unknown
Registered
2020-11-22
Start date
2020-11-30
Completion date
Unknown
Last updated
2023-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cardiovascular diseases

Interventions

Experiment group:standard on-pump cardiac surgery+oral colchicine
Control group:standard on-pump cardiac surgery+oral placebo

Sponsors

Nanjing Drum Tower Hospital, The affiliated Hospital of Nanjing University Medical School
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Adult patients undergoing on-pump cardiovascular surgery; 2. Aged 50-75 (including 50 and 75), male or female; 3. Have signed the Informed Consent Form (ICF); 4. Patients have New York Heart Association Class I-II.

Exclusion criteria

Exclusion criteria: 1. Patients undergoing emergency surgery; 2. Patients undergoing deep hypothermic circulatory arrest (DHCA) surgery; 3. Patients with atrial fibrillation who need radiofrequency catheter ablation (RFCA); 4. Patients with coronary artery disease (CAD) who need percutaneous transluminal coronary intervention (PCI) or CABG; 5. Poor hepatorenal dysfunction (Child Pugh Class B or C, eGFR 10 pg/ml, PCT > 0.5 ng/ml, CRP > 10 mg/L); 7. Predicitive mortality of European System for Cardiac Operative Risk Evaluation (EuroScore II) > 3% 8. Patients who had received cardiac surgery; 9. Patients who are diagnosed with inflammatory immune diseases; 10. Patients who received treatment of colchicine or hormone previously; 11. Patients who had history of tumor or infectious disease; 12. Patients who had colchicine allergy or intolerance; 13. Patients who receive more than 120 min of aortic cross clamp (ACC); 14. Patients who need ventricular outflow reconstruction in the surgery.

Design outcomes

Primary

MeasureTime frame
Troponin T;

Secondary

MeasureTime frame
blood routine examination;Erythrocyte sedimentation rate;PCT;Myocardial enzyme profile;Biochemical complete inspection;CRP;Troponin I;

Countries

China

Contacts

Public ContactWang Dongjin

Nanjing Drum Tower Hospital, The affiliated Hospital of Nanjing University Medical School

wangdongjin@njglyy.com+86 13915980346

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 13, 2026