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Silymarin for the Prevention of Atrial Fibrillation After Cardiac Surgery

NCT ID: NCT06114719

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-09-30

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).

Conditions

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Atrial Fibrillation New Onset

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Experimental group

Silymarin 400 mg daily, orally, divided into two doses, for three days preoperatively

Group Type EXPERIMENTAL

Silymarin

Intervention Type 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).

Control group

Optimal standard therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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).

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Novi Sad

OTHER

Sponsor Role lead

Responsible Party

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Mihaela Preveden

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Institute of Cardiovascular Diseases of Vojvodina

Kamenitz, , Serbia

Site Status

Countries

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Serbia

Other Identifiers

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661-1/1

Identifier Type: -

Identifier Source: org_study_id