'A Prospective Randomized Trial to Assess the Impact of Ascorbic Acid on Outcomes and Complications Post Cardiac Surgeries''
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Risk of arrhythmia post operative
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Elective Cardiac surgery
- •American Society of Anesthesiologists physical status class I-III
Exclusion Criteria
- •Allergy to ascorbic acid
- •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
Arms & Interventions
Ascorbic acid
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.
Intervention: Ascorbic Acid 500Mg Chew Tab (Drug)
Placebo group
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.
Intervention: Carbonated orange beverage (Other)
Outcomes
Primary Outcomes
Risk of arrhythmia post operative
Time Frame: 7 days post operative
assessing risk of AF post surgical using ECG
pain management
Time Frame: 2 days post operative
Evaluating cumulative dose of opioid administered within ICU stay in the two groups
wound healing
Time Frame: 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)
Secondary Outcomes
No secondary outcomes reported