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

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

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

Study Overview

• Status: Unknown
• Conditions: Cardiothoracic Surgery
• Intervention / Treatment: Drug: Ascorbic Acid 500Mg Chew Tab; Other: Carbonated orange beverage

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Tamer M Ayed, MD; Phone Number: 01006045615; Email: Tamerayed70@gmail.com

Study Locations

• Egypt
  • Sheraton
    • Cairo, Sheraton, Egypt, 11651
      • Recruiting
      • Galaa Military Medical Complex
      • Contact: Tamer M Ayed, MD
      • Principal Investigator: Tamer M Ayed, MD
      • Principal Investigator: Walid R Abdelfattah, MSc
      • Principal Investigator: Nehal A Hassan, MSc
      • Principal Investigator: Fathi M Aboushareb, MSc
      • Principal Investigator: Nourhane A Ibrahim, MSc
      • Principal Investigator: Kareem E Eltoukhy, MSc
      • Principal Investigator: Romel B Barsoum, MSc
      • Principal Investigator: Maged A Mohamed, MSc
      • Principal Investigator: George S Hanna, BSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Ascorbic Acid 500Mg Chew Tab; Ascorbic acid will be administered at the night before surgery and will be continued for five days
Placebo Comparator: 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.	Other: Carbonated orange beverage; The carbonated orange beverage will be administered at the night before surgery and will be continued for five days

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: El-Galaa Military Medical Complex

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2018
• Primary Completion (Anticipated): April 15, 2019
• Study Completion (Anticipated): August 15, 2019

Study Registration Dates

• First Submitted: August 13, 2018
• First Submitted That Met QC Criteria: August 19, 2018
• First Posted (Actual): August 21, 2018

Study Record Updates

• Last Update Posted (Actual): August 21, 2018
• Last Update Submitted That Met QC Criteria: August 19, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Ascorbic Acid
• Other Study ID Numbers: GMMC-RC18-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No