The Impact of Oral Vitamin C in Prevention for Post Operative Atrial Fibrillation (POAF) in Coronary Artery Bypass Surgery (CABG) Patients

NCT06074367 | Unknown Phase 4

• 1 other identifier: Vitamin C in POAF prevention
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Post operative atrial fibrillation (POAF) is one of the most common complications that takes place worldwide after coronary artery bypass surgeries (CABG). Many studies suggest using vitamin C as an additional treatment alongside standard therapies, such as statins and β-blockers, to reduce the risk of postoperative atrial fibrillation (POAF) in patients undergoing (CABG). Supplemental therapy with vitamin C may provide a more robust preventive effect against POAF compared to using statins and β-blockers due to its strong antioxidant effect. This implies that vitamin C can enhance the effectiveness of those medications used for POAF prevention by decreasing oxidative stress induced by the surgery. There are conflicting data on whether or not vitamin C as an antioxidant has a protective effect against postoperative atrial fibrillation and has a significant role in shortening length of ICU and hospital stay . Even in those studies that show positive relationship of vitamin C in AF prevention, there is a diversity in the dosing regimen of vitamin C used among those previous studies. To the best of our knowledge, most researches were conducted predominantly within a single geographic region, such as Iran, this raises the concerns about the potential bias and limits our ability to apply the findings to a broader global population. Here, the investigators aimed to evaluate the effectiveness of vitamin C supplementation and to figure out which dose of vitamin C will prevent post-operative AF and decrease complications such as hospital stay, pneumonia and surgical site infection among older Egyptian adults.

Conditions

Post Operative Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Postoperative atrial fibrillation (POAF) incidence in patients undergoing coronary artery bypass (CABG) surgery through the administration of vitamin C supplementation compared to placebo group

  Evaluate the effectiveness of perioperative oral vitamin C in prevention for post operative AF following elective on-pump coronary artery bypass surgery in old adult Egyptian. patients during hospital stay.

  through hospital stay , an average of 7 days

• compare between high dose verses low dose of vitaminC

  Quantify the effective dose of perioperative oral vitamin C on the incidence of the POAF during hospital stay following elective on-pump CABG surgery in old adult Egyptian patients.

  through hospital stay, an average of 7 days

Secondary Outcomes (1)

• Lenght of hospital stay

  through hospital stay, an average of 7 days

Study Arms (3)

GROUP 1 (2g Vitamin C )

EXPERIMENTAL

Drug: Vitamin C 500 MG Oral Capsule(High dose 2g daily)

GROUP 2 (1g Vitamin C )

EXPERIMENTAL

Drug: Vitamin C 500 MG Oral Capsule(Low-dose 1g daily)

Control group

PLACEBO COMPARATOR

Drug: placebo capsules

Interventions

Vitamin C 500 MG Oral Capsule(High dose 2g daily) DRUG

A sixty CABG patients commenced on maximum tolerated dose of b-blocker, statins \& vitamin C 500 mg (2 g-daily in 4 divided doses) started one day before operation till the end of hospital stay or development of post operative atrial fibrillation

GROUP 1 (2g Vitamin C )

Vitamin C 500 MG Oral Capsule(Low-dose 1g daily) DRUG

A sixty CABG patients commenced on maximum tolerated dose of b-blocker, statins, vitamin C 500 mg (1 g-daily in 2 divided doses) and also received 2 capsules containing starch to be completely equivalent in frequency to the other groups. the intervention started one day before operation till the end of hospital stay or development of post operative atrial fibrillation.

GROUP 2 (1g Vitamin C )

placebo capsules DRUG

A sixty CABG Patients commenced on maximum tolerated dose of b-blocker, statins and placebo capsules containing starch mimic vitamin C capsules was taken every 6 hrs. The placebo capsules were prepared in the same shape and size as the original ones manufactured by the same pharmaceutical company. the intervention started one day before operation till the end of hospital stay or development of post operative atrial fibrillation.

Control group

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who underwent elective isolated on-pump coronary artery bypass surgery
• Age: 50 to 70 years
• No history of Coronary artery by pass surgery
• Taking maximum tolerated beta-blocker before and after surgery
• Normal left atrium and left ventricle dimensions

You may not qualify if:

• preoperative history of Atrial fibrilliation
• permanent pacemaker or significant bradycardia
• Hyperoxaluria or history of nephrolithiasis
• Left ventricular ejection fraction \< 40%
• Contraindications to beta-blocker or vitamin C.
• Patients with history of vitamin C consumption before surgery.
• Chronic kidney disease with creatinine \>2 mg/dl.

Sponsors & Collaborators

• Helwan University: lead

Study Sites (1)

El Sheik Zayed Specialized Hospital

Giza, 3210001, Egypt

Location

MeSH Terms

Interventions

Ascorbic Acid

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The study was double blinded were Participant (patients), Care Provider (nurses, cardiac surgeons, and ICU physicians) were blinded but the outcome assessors (clinical pharmacist) who collect data were not blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: October 10, 2023
• Study Start: October 13, 2020
• Primary Completion: October 15, 2023
• Study Completion: October 30, 2023
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)