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

NCT ID: NCT03639519

Last Updated: 2018-08-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-15
• Study Completion Date: 2019-08-15

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.

Conditions

Cardiothoracic Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Ascorbic Acid 500Mg Chew Tab

Intervention Type: DRUG

Ascorbic acid will be administered at the night before surgery and will be continued for five days

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.

Group Type: PLACEBO_COMPARATOR

Carbonated orange beverage

Intervention Type: OTHER

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

Interventions

Ascorbic Acid 500Mg Chew Tab

Ascorbic acid will be administered at the night before surgery and will be continued for five days

Intervention Type: DRUG

Carbonated orange beverage

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

El-Galaa Military Medical Complex

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Galaa Military Medical Complex

Cairo, Sheraton, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Tamer M Ayed, MD

Role: CONTACT

Tamerayed70@gmail.com

01006045615

Facility Contacts

Tamer M Ayed, MD

Role: primary

Other Identifiers

GMMC-RC18-2

Identifier Type: -

Identifier Source: org_study_id