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

Phase 4

• Conditions: Cardiothoracic Surgery
• Interventions: Drug: Ascorbic Acid 500Mg Chew Tab; Other: Carbonated orange beverage

• Registration Number: NCT03639519
• Lead Sponsor: El-Galaa Military Medical Complex

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 Timeline

• Study Start: 2018-04-15
• Status Verified: 2018-08
• Study First Submitted: 2018-08-13
• Study First Submitted QC: 2018-08-19
• Last Update Submitted: 2018-08-19
• Study First Posted: 2018-08-21
• Last Update Posted: 2018-08-21
• Primary Completion: 2019-04-15
• Study Completion: 2019-08-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ascorbic acid	Ascorbic Acid 500Mg Chew Tab	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	Carbonated orange beverage	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.

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Galaa Military Medical Complex; 🇪🇬 Cairo, Sheraton, Egypt