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

January 31, 2024 updated by: Ain Shams University
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
350

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Marwa Adel, PhD

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Ain shams university
        • Contact:
          • noha tarek
          • Phone Number: 01007541786

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
• Number of Participants with POAF
Time Frame: 1 month
1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total intensive care unit length-of-stay
Time Frame: 3 months
number of days at intensive care unit
3 months
Total hospital length-of-stay
Time Frame: 3 months
number of days at hospital
3 months
30 days mortality
Time Frame: 1-month
deaths number
1-month
Serum creatinine
Time Frame: 5 days
creatinine level
5 days
Major adverse cardiovascular outcomes
Time Frame: 1 month
(Myocardial injury - Stroke - Permanent pacemaker - Pericardial effusion and pleural effusion- Bleeding)
1 month
Duration of ventilation
Time Frame: 5 days
hours needed to remove ventilator
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ain Shams University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Marwa Adel, PhD, Ain shams university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 24, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 30, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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