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

Postoperative Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06151652
• Other study ID #: ALA post cardiac surgery
• Status: Recruiting
• Phase: Phase 4
• Start date: January 1, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: September 2023
• Source: Ain Shams University
• Contact: noha tarek mohammed, MSC
• Phone: 00201007541786
• Email: noha.tarek20[@]pharma.asu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: April 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Postoperative Atrial Fibrillation

Intervention

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.
• Placebo
placebo

Locations

Country	Name	City	State
Egypt	Ain shams university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• Number of Participants with POAF		1 month
Secondary	Total intensive care unit length-of-stay	number of days at intensive care unit	3 months
Secondary	Total hospital length-of-stay	number of days at hospital	3 months
Secondary	30 days mortality	deaths number	1-month
Secondary	Serum creatinine	creatinine level	5 days
Secondary	Major adverse cardiovascular outcomes	(Myocardial injury - Stroke - Permanent pacemaker - Pericardial effusion and pleural effusion- Bleeding)	1 month
Secondary	Duration of ventilation	hours needed to remove ventilator	5 days