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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (Control group, N = 175 patients) | Placebo Comparator | which will include patients adopted to the hospital standard of care. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| • Number of Participants with POAF | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Total intensive care unit length-of-stay | number of days at intensive care unit | 3 months |
| Total hospital length-of-stay | number of days at hospital |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| noha tarek mohammed, MSC | Contact | 00201007541786 | noha.tarek20@pharma.asu.edu.eg | |
| Marwa Adel, PhD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Marwa Adel, PhD | Ain Shams University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain shams university | Recruiting | Cairo | Egypt |
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| ID | Term |
|---|---|
| D008063 | Thioctic Acid |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| Placebo | Drug | placebo |
|
| 3 months |
| 30 days mortality | deaths number | 1-month |
| Serum creatinine | creatinine level | 5 days |
| Major adverse cardiovascular outcomes | (Myocardial injury - Stroke - Permanent pacemaker - Pericardial effusion and pleural effusion- Bleeding) | 1 month |
| Duration of ventilation | hours needed to remove ventilator | 5 days |
| D003067 |
| Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |