NCT06151652

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Postoperative Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	Alpha Lipoic Acid 600 MG Oral Tablet	Alpha-lipoic acid (Thiotacid 600 mg ®) at a dose of 600 mg three times daily for one day prior to surgery, followed by Alpha-lipoic acid 600 mg twice daily for 5 days post-surgery plus the standard care.
DRUG	Placebo	placebo

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-03-01
• Completion: 2024-04-01
• First posted: 2023-11-30
• Last updated: 2024-02-01

Locations

1 site across 1 country: Egypt