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

NCT03639519 | Unknown Phase 4 DMC

• 1 other identifier: GMMC-RC18-2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Cardiothoracic Surgery

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Ascorbic acid

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

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

Interventions

Ascorbic Acid 500Mg Chew Tab DRUG

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

Ascorbic acid

Carbonated orange beverage OTHER

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

Placebo group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective Cardiac surgery
• American Society of Anesthesiologists physical status class I-III

You may not qualify if:

• 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

Sponsors & Collaborators

• El-Galaa Military Medical Complex: lead

Study Sites (1)

Galaa Military Medical Complex

Cairo, Sheraton, 11651, Egypt

RECRUITING

MeSH Terms

Interventions

Ascorbic Acid; Mastication

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Eating; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Central Study Contacts

Tamer M Ayed, MD

CONTACT

01006045615; Tamerayed70@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: August 21, 2018
• Study Start: April 15, 2018
• Primary Completion: April 15, 2019
• Study Completion: August 15, 2019
• Last Updated: August 21, 2018

Record last verified: 2018-08

Locations

EG (1)