Effect of Alpha-Lipoic Acid Supplementation on the Incidence of Postoperative Atrial Fibrillation in Cardiac Surgery Patients

Last updated: January 31, 2024
Sponsor: Ain Shams University
Overall Status: Active - Recruiting

Phase

4

Condition

Arrhythmia

Chest Pain

Atrial Fibrillation

Treatment

Placebo

Alpha Lipoic Acid 600 MG Oral Tablet

Clinical Study ID

NCT06151652
ALA post cardiac surgery
  • Ages 18-75
  • All Genders

Study Summary

ALA is administered orally since it is without difficulty absorbed in the stomach. ALA goes through the blood brain barrier and does not show toxic effects and actions at doses used for prophylactic and therapeutic purposes. This has encouraged us to use an efficient anti-oxidant and anti-inflammatory agent, alpha-lipoic acid (biochemical) as a relevant option to prevent POAF.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • I
  • Male or female patients above 18 years of age who are scheduled for cardiac surgery.

Exclusion

Exclusion Criteria:

  • Any urgent or emergency surgery.
  • Poor Left ejection volume (EF < 30%).
  • Intake of steroids or any antiarrhythmic drugs except beta blockers during the lastmonth before surgery
  • Unable or unwilling to provide informed written consent.
  • Pregnancy or lactation
  • Known hypersensitivity to the study drug.
  • Current treatment with antioxidants or alpha-lipoic acid for any indication.
  • Infection or inflammatory disease except coronary artery disease.
  • Left atrium size >70 mm.

Study Design

Total Participants: 350
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 4
Study Start date:
January 01, 2023
Estimated Completion Date:
April 01, 2024

Study Description

Investigators computed on the basis of findings from a prior study found the incidence of POAF after cardiac surgery of about 25% . Assuming a slightly lower alpha-lipoic acid' effect to previous study. If the true relative risk of AF for experimental subjects relative to controls is 0.5 , with α equivalent to 0.5 and power (1 - β) is 0.8, the estimated sample size is 152 experimental subjects and 152 control subjects in order to be able to reject the null hypothesis that this relative risk equals 1 with probability (power) of 0.8. investigators used the uncorrected chi-squared statistics to evaluate this null hypothesis. STATA software version and taking into account a possible dropout of 15%, the total sample size was: 304 + 0.15 (304) × 2 = 350 subjects of which there will be 175 controls and 175 experimental subjects %, assuming an enrolment ratio of 1:1.

Connect with a study center

  • Ain shams university

    Cairo,
    Egypt

    Active - Recruiting

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