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

NCT06151652 | Unknown Phase 4

• 1 other identifier: ALA post cardiac surgery
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• • Number of Participants with POAF

  1 month

Secondary Outcomes (6)

• Total intensive care unit length-of-stay

  3 months

• Total hospital length-of-stay

  3 months

• 30 days mortality

  1-month

• Serum creatinine

  5 days

• Major adverse cardiovascular outcomes

  1 month

Study Arms (2)

Group 1 (Control group, N = 175 patients)

PLACEBO COMPARATOR

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

Drug: Placebo

Group 2 (Test group, N = 175 patients)

ACTIVE COMPARATOR

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

Interventions

Alpha Lipoic Acid 600 MG Oral Tablet 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.

Group 2 (Test group, N = 175 patients)

Placebo DRUG

placebo

Group 1 (Control group, N = 175 patients)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Thioctic Acid; Tablets

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Marwa Adel, PhD

  Ain Shams University

  STUDY DIRECTOR

Central Study Contacts

noha tarek mohammed, MSC

CONTACT

00201007541786; noha.tarek20@pharma.asu.edu.eg

Marwa Adel, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2023
• First Posted: November 30, 2023
• Study Start: January 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: April 1, 2024
• Last Updated: February 1, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)