Silymarin for the Prevention of Atrial Fibrillation After Cardiac Surgery
- Registration Number
- NCT06114719
- Lead Sponsor
- University of Novi Sad
- Brief Summary
The study is a prospective, randomized, controlled trial to assess the effects of silymarin on the occurrence of postoperative atrial fibrillation after coronary artery bypass graft surgery.
- Detailed Description
Postoperative atrial fibrillation (POAF) is a frequent complication after coronary artery bypass graft (CABG) surgery and is associated with increased mortality. So far, the effects of various drugs and supplements on the occurrence of postoperative atrial fibrillation (POAF) have been studied, but no one has looked into the effect of silymarin on the occurrence of POAF.
The study is designed as a prospective, randomized, controlled trial to assess the effects of silymarin on the occurrence of postoperative atrial fibrillation after CABG surgery. A total of 160 patients of both sexes scheduled for elective CABG surgery using cardiopulmonary bypass (CPB) will be included. They will be randomized into two groups (experimental and control) with 80 patients each. Subjects in the experimental group will receive 400 mg of silymarin three days preoperatively, while subjects in the control group will receive standard therapy.
The occurrence of POAF after CABG surgery will be the primary outcome, which will be defined as any dysrhythmia that represents the ECG characteristics of atrial fibrillation lasting at least 30 s on a rhythm strip or 12-lead ECG. Secondary outcomes will include postoperative values of inflammation markers, length of stay in the ICU, length of hospitalization, and occurrence of postoperative complications (pericardial effusion, stroke, in-hospital death).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
- scheduled for elective CABG surgery using cardiopulmonary bypass
- first cardiac surgery
- left ventricular ejection fraction > 35%
- less than moderate mitral regurgitation
- preoperative atrial fibrillation
- previous history of interventionally treated arrhythmias
- end-stage renal disease requiring hemodialysis
- chronic inflammatory and neoplastic diseases
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group Silymarin Silymarin 400 mg daily, orally, divided into two doses, for three days preoperatively
- Primary Outcome Measures
Name Time Method Number of participants with postoperative atrial fibrillation 4 days Occurrence of postoperative atrial fibrillation lasting at least 30 s on a rhythm strip or 12-lead ECG
- Secondary Outcome Measures
Name Time Method ICU length of stay 30 days Total duration of stay in the intensive care unit
Hospital length of stay 30 days Total duration of stay in hospital
Postoperative complications 30 days Occurrence of postoperative complications including pericardial effusion, stroke, and in-hospital death
Blood concentration of white blood cells 4 days Postoperative values of white blood cells
Blood concentration of C-reactive protein 4 days Postoperative values of C-reactive protein
Trial Locations
- Locations (1)
Institute of Cardiovascular Diseases of Vojvodina
🇷🇸Sremska Kamenica, Serbia