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

El-Galaa Military Medical Complex

Status and phase: Unknown; Phase 4

Conditions: Cardiothoracic Surgery

Treatments: Drug: Ascorbic Acid 500Mg Chew Tab; Other: Carbonated orange beverage

Study type: Interventional

Funder types: Other

Identifiers

NCT03639519

GMMC-RC18-2

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

Ascorbic acid

Experimental group

Description:

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.

Treatment:

Drug: Ascorbic Acid 500Mg Chew Tab

Placebo group

Placebo Comparator group

Description:

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.

Treatment:

Other: Carbonated orange beverage