The Effect of Colchicine on the Occurrence of Atrial Fibrillation After Cardiac Surgery
Recruiting · NCT06798714 · Interventional (participants receive a specific treatment) · Lead sponsor: Tomsk Cardiology Research Institute
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Development of a new comprehensive method for perioperative prevention of atrial fibrillation paroxysms in cardiac surgery patients at the hospital stage. It is planned to recruit 70 patients who will undergo pericardial fenestration during the operation using the original technique during coronary artery bypass grafting (Patent No. 2647626 C1 Russian Federation), and will be prescribed colchicine (the drug "Colchicum-dispert") in the perioperative period in order to prevent the development of paroxysms of atrial fibrillation in the postoperative period, and 70 cardiac surgery patients operated on using the standard technique (without performing the pericardial fenestration procedure intraoperatively), receiving non-steroidal anti-inflammatory drugs in the postoperative period.
Who can take part
Inclusion criteria
- Elective coronary artery bypass grafting on pump;
- signed informed consent to participate in the study.
Exclusion criteria
- Reduced left ventricular ejection fraction (≤35%);
- Valvular heart disease requiring surgical correction;
- Liver failure with an increase in liver transaminases ≥1.5 times;
- Renal failure (GFR\<35 mL/min/1.73 m2 calculated with CKD-EPI);
- Permanent, persistent or paroxysmal atrial fibrillation;
- Previously implanted pacemaker;
- Hypersensitivity to colchicine;
- Neutropenia;
- History of alcoholism;
- Refusal to sign informed consent
Where it is running
1 location listed.
- Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences, Tomsk, Russia - Tomsk, Russia