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

Cardiothoracic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03639519
• Other study ID #: GMMC-RC18-2
• Status: Recruiting
• Phase: Phase 4
• Start date: April 15, 2018
• Est. completion date: August 15, 2019

Study information

• Verified date: August 2018
• Source: El- Galaa Military Medical Compound
• Contact: Tamer M Ayed, MD
• Phone: 01006045615
• Email: Tamerayed70[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 15, 2019
• Est. primary completion date: April 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiothoracic Surgery

Intervention

Drug:
• Ascorbic Acid 500Mg Chew Tab
Ascorbic acid will be administered at the night before surgery and will be continued for five days

Other:
• Carbonated orange beverage
The carbonated orange beverage will be administered at the night before surgery and will be continued for five days

Locations

Country	Name	City	State
Egypt	Galaa Military Medical Complex	Cairo	Sheraton

Sponsors (1)

Lead Sponsor	Collaborator
El- Galaa Military Medical Compound

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk of arrhythmia post operative	assessing risk of AF post surgical using ECG	7 days post operative
Primary	pain management	Evaluating cumulative dose of opioid administered within ICU stay in the two groups	2 days post operative
Primary	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