Silymarin for the Prevention of Atrial Fibrillation After Cardiac Surgery

Study Overview
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Brief Summary
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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
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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).

Official Title
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The Effect of Silymarin on the Prevention of Atrial Fibrillation After Coronary Artery Bypass Graft Surgery

Conditions
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Atrial Fibrillation New Onset

Intervention / Treatment
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* Drug: Silymarin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: scheduled for elective CABG surgery using cardiopulmonary bypass first cardiac surgery left ventricular ejection fraction > 35% less than moderate mitral regurgitation Exclusion Criteria: preoperative atrial fibrillation previous history of interventionally treated arrhythmias end-stage renal disease requiring hemodialysis chronic inflammatory and neoplastic diseases

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Silymarin 400 mg daily, orally, divided into two doses, for three days preoperatively | Drug: Silymarin<br>* Subjects of the experimental group will receive silymarin (capsules containing 100 mg silymarin, expressed as silibinin) three days preoperatively. The dose they receive will be the recommended dose for the registered indications (400 mg daily, orally, divided into two doses).<br>|
| No Intervention: Control group<br>Optimal standard therapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with postoperative atrial fibrillation | Occurrence of postoperative atrial fibrillation lasting at least 30 s on a rhythm strip or 12-lead ECG | 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU length of stay | Total duration of stay in the intensive care unit | 30 days | 
| Hospital length of stay | Total duration of stay in hospital | 30 days | 
| Postoperative complications | Occurrence of postoperative complications including pericardial effusion, stroke, and in-hospital death | 30 days | 
| Blood concentration of white blood cells | Postoperative values of white blood cells | 4 days | 
| Blood concentration of C-reactive protein | Postoperative values of C-reactive protein | 4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac surgery, postoperative atrial fibrillation, silymarin