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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03639519
Other study ID # GMMC-RC18-2
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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