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

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Atrial Fibrillation
• Intervention / Treatment: Drug: Placebo; Drug: Alpha Lipoic Acid 600 MG Oral Tablet

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.

• Study Type: Interventional
• Enrollment (Estimated): 350
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: noha tarek mohammed, MSC; Phone Number: 00201007541786; Email: noha.tarek20@pharma.asu.edu.eg
• Study Contact Backup: Name: Marwa Adel, PhD

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Ain Shams University
    • Contact: noha tarek; Phone Number: 01007541786

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

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 last month 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group 1 (Control group, N = 175 patients); which will include patients adopted to the hospital standard of care.	Drug: Placebo; placebo
Active Comparator: Group 2 (Test group, N = 175 patients); which will include patients who will receive 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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
• Number of Participants with POAF	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total intensive care unit length-of-stay	number of days at intensive care unit	3 months
Total hospital length-of-stay	number of days at hospital	3 months
30 days mortality	deaths number	1-month
Serum creatinine	creatinine level	5 days
Major adverse cardiovascular outcomes	(Myocardial injury - Stroke - Permanent pacemaker - Pericardial effusion and pleural effusion- Bleeding)	1 month
Duration of ventilation	hours needed to remove ventilator	5 days

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Marwa Adel, PhD, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: September 24, 2023
• First Submitted That Met QC Criteria: November 21, 2023
• First Posted (Actual): November 30, 2023

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Vitamin B Complex; Thioctic Acid
• Other Study ID Numbers: ALA post cardiac surgery

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No