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

NCT ID: NCT06074367

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-13
• Study Completion Date: 2023-10-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

GROUP 1 (2g Vitamin C )

Group Type: EXPERIMENTAL

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

Intervention Type: 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 2 (1g Vitamin C )

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Control group

Group Type: PLACEBO_COMPARATOR

placebo capsules

Intervention Type: 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.

Interventions

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

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

Intervention Type: DRUG

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

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.

Intervention Type: DRUG

placebo capsules

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helwan University

OTHER

Sponsor Role: lead

Responsible Party

Sahar Mohamed Hesham

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

El Sheik Zayed Specialized Hospital

Giza, , Egypt

Countries

Egypt

Other Identifiers

Vitamin C in POAF prevention

Identifier Type: -

Identifier Source: org_study_id