Clinical trial NCT06114719: Silymarin for the Prevention of Atrial Fibrillation After Cardiac Surgery
Official title: The Effect of Silymarin on the Prevention of Atrial Fibrillation After Coronary Artery Bypass Graft Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation New Onset
Keywords: cardiac surgery
postoperative atrial fibrillation
silymarin
Lead sponsor: University of Novi Sad
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with postoperative atrial fibrillation
timeFrame: 4 days
Secondary outcomes:
measure: ICU length of stay
timeFrame: 30 days
measure: Hospital length of stay
timeFrame: 30 days
measure: Postoperative complications
timeFrame: 30 days
measure: Blood concentration of white blood cells
timeFrame: 4 days
measure: Blood concentration of C-reactive protein
timeFrame: 4 days
Other outcomes:
Locations:
city: Sremska Kamenica
country: Serbia
facility: Institute of Cardiovascular Diseases of Vojvodina
Study officials:
References: