Silymarin for the Prevention of Atrial Fibrillation After Cardiac Surgery

December 3, 2024 updated by: Mihaela Preveden, University of Novi Sad

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Serbia
      • Sremska Kamenica, Serbia, 21204
        • Institute of Cardiovascular Diseases of Vojvodina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Silymarin 400 mg daily, orally, divided into two doses, for three days preoperatively
Drug: Silymarin
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).
No Intervention: Control group
Optimal standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Novi Sad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

September 1, 2024

Study Completion (Actual)

September 30, 2024

Study Registration Dates

First Submitted

October 29, 2023

First Submitted That Met QC Criteria

October 29, 2023

First Posted (Actual)

November 2, 2023

Study Record Updates

Last Update Posted (Estimated)

December 4, 2024

Last Update Submitted That Met QC Criteria

December 3, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 661-1/1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atrial Fibrillation New Onset

Clinical Trials on Silymarin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe