Postoperative Atrial Fibrillation
Conditions
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.
Interventions
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.
DRUGPlacebo
placebo
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Number of Participants with POAF | 1 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total hospital length-of-stay | 3 months | number of days at hospital |
| 30 days mortality | 1-month | deaths number |
| Total intensive care unit length-of-stay | 3 months | number of days at intensive care unit |
| Major adverse cardiovascular outcomes | 1 month | (Myocardial injury - Stroke - Permanent pacemaker - Pericardial effusion and pleural effusion- Bleeding) |
| Duration of ventilation | 5 days | hours needed to remove ventilator |
| Serum creatinine | 5 days | creatinine level |
Countries
Egypt
Contacts
Primary Contactnoha tarek mohammed, MSC
Backup ContactMarwa Adel, PhD
Outcome results
None listed