Cardiothoracic Surgery
Conditions
Brief summary
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
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.
Interventions
DRUGAscorbic Acid 500Mg Chew Tab
Ascorbic acid will be administered at the night before surgery and will be continued for five days
OTHERCarbonated orange beverage
The carbonated orange beverage will be administered at the night before surgery and will be continued for five days
Sponsors
El-Galaa Military Medical Complex
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Risk of arrhythmia post operative | 7 days post operative | assessing risk of AF post surgical using ECG |
| pain management | 2 days post operative | Evaluating cumulative dose of opioid administered within ICU stay in the two groups |
| wound healing | 30 days post operative | 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) |
Countries
Egypt
Contacts
Primary ContactTamer M Ayed, MD
Outcome results
None listed