A Trial to Assess the Impact of Ascorbic Acid on Cardiac Surgeries Outcomes and Complications''

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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'A Prospective Randomized Trial to Assess the Impact of Ascorbic Acid on Outcomes and Complications Post Cardiac Surgeries''

Conditions
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Cardiothoracic Surgery

Intervention / Treatment
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* Drug: Ascorbic Acid 500Mg Chew Tab
* Other: Carbonated orange beverage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective Cardiac surgery American Society of Anesthesiologists physical status class I-III Exclusion Criteria: Allergy to ascorbic acid Asthma COPD Allergy to opioids Previous history of chemical dependence Prior cardiac surgery Known hyperoxaluria History of renal calculi History of allergic or hypersensitivity reaction to ascorbic acid products Currently taking 1 g or more of ascorbic acid supplementation daily

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ascorbic acid<br>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. | Drug: Ascorbic Acid 500Mg Chew Tab<br>* Ascorbic acid will be administered at the night before surgery and will be continued for five days<br>|
| Placebo Comparator: Placebo group<br>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. | Other: Carbonated orange beverage<br>* The carbonated orange beverage will be administered at the night before surgery and will be continued for five days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |