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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06114719
Other study ID # 661-1/1
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date January 1, 2023
Est. completion date July 1, 2025

Study information

Verified date November 2023
Source University of Novi Sad
Contact Bogdan Okiljevic
Phone +381214805702
Email bogdanokiljevic@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 160
Est. completion date July 1, 2025
Est. primary completion date January 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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).

Locations

Country Name City State
Serbia Institute of Cardiovascular Diseases of Vojvodina Sremska Kamenica

Sponsors (1)

Lead Sponsor Collaborator
University of Novi Sad

Country where clinical trial is conducted

Serbia, 

Outcome

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