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

NCT ID: NCT06151652

Last Updated: 2024-02-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2024-04-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Group 1 (Control group, N = 175 patients)

which will include patients adopted to the hospital standard of care.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo

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.

Group Type: ACTIVE_COMPARATOR

Alpha Lipoic Acid 600 MG Oral Tablet

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Placebo

placebo

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marwa Adel, PhD

Role: STUDY_DIRECTOR

Ain Shams University

Locations

Ain shams university

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

noha tarek mohammed, MSC

Role: CONTACT

noha.tarek20@pharma.asu.edu.eg

00201007541786

Marwa Adel, PhD

Role: CONTACT

Facility Contacts

noha tarek

Role: primary

01007541786

Other Identifiers

ALA post cardiac surgery

Identifier Type: -

Identifier Source: org_study_id