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NCT Number: NCT06114719

Silymarin for the Prevention of Atrial Fibrillation After Cardiac Surgery

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Institute of Cardiovascular Diseases of Vojvodina

Kamenitz, 21204, Serbia

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Silymarin

Drug

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).

Primary outcomes

  1. Number of participants with postoperative atrial fibrillation

    Time frame: 4 days

    Occurrence of postoperative atrial fibrillation lasting at least 30 s on a rhythm strip or 12-lead ECG

Secondary outcomes

  1. ICU length of stay

    Time frame: 30 days

    Total duration of stay in the intensive care unit

  2. Hospital length of stay

    Time frame: 30 days

    Total duration of stay in hospital

  3. Postoperative complications

    Time frame: 30 days

    Occurrence of postoperative complications including pericardial effusion, stroke, and in-hospital death

  4. Blood concentration of white blood cells

    Time frame: 4 days

    Postoperative values of white blood cells

  5. Blood concentration of C-reactive protein

    Time frame: 4 days

    Postoperative values of C-reactive protein

Sponsors and collaborators

Lead sponsor

University of Novi Sad

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 2, 2023
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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