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this study is evaluating the safety and efficacy of ascorbic acid as a drug that can decrease inflammatory complications post surgical in addition to its impact on decreasing risk of arrhythmia and total opioid administration post operative
The study will include two arm of patients who are scheduled for elective cardiac surgery, either coronary artery bypass grafting (CABG) or Valvular replacement First arm: Patients will take 2 g orally ascorbic acid effervescent tablets the night before cardiac surgery, then 1 g twice daily for 5 days after surgery in addition to their traditional medical care. Second arm: will not be given ascorbic acid , instead a placebo 9orange carbonated beverage) will be used, and will be given the rest of traditional medical care provided to the first arm. Inflammatory markers C- reactive protein (CRP), erythrocyte sedimentation rate (ESR) and differential total leukocytic count (TLC), serum urea and creatinine, ALT, AST, CK-mb, CK-Total, aPTT, INR, Hemoglobin, platelet count, will be assessed on day 0, 1,2,4,6 postoperative in both arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ascorbic acid | Experimental | Patients will take 2 g orally ascorbic acid effervescent tablets the night before cardiac surgery, then 1 g twice daily for 5 days after surgery in addition to their traditional medical care. |
|
| Placebo group | Placebo Comparator | will not be given ascorbic acid , instead a placebo will be used, and will be given the rest of traditional medical care provided to the first arm. Inflammatory markers (CRP, ESR and differential TLC), serum urea and creatinine, ALT, AST, CK-mb, CK-Total, aPTT, INR, Hemoglobin, platelet count, will be assessed on day 0, 1,2,4,6 postoperative in both arms. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ascorbic Acid 500Mg Chew Tab | Drug | Ascorbic acid will be administered at the night before surgery and will be continued for five days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Risk of arrhythmia post operative | assessing risk of AF post surgical using ECG | 7 days post operative |
| pain management | Evaluating cumulative dose of opioid administered within ICU stay in the two groups | 2 days post operative |
| wound healing | assessment of wound inflammation and infection risk using ASEPSIS score (a scoring system to assess wound healing and evaluate the presence of infection, a score between 10 to 20 means disturbed healing, >20 points means infected wound, >30 means moderate to sever infection) | 30 days post operative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tamer M Ayed, MD | Contact | 01006045615 | Tamerayed70@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galaa Military Medical Complex | Recruiting | Cairo | Sheraton | 11651 | Egypt |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| D008409 | Mastication |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Carbonated orange beverage | Other | The carbonated orange beverage will be administered at the night before surgery and will be continued for five days |
|
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |
| D004435 | Eating |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D004068 | Digestive System Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |