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

H

Helwan University

Status and phase

Active, not recruiting
Phase 4

Conditions

Post Operative Atrial Fibrillation

Treatments

Drug: placebo capsules
Drug: Vitamin C 500 MG Oral Capsule(High dose 2g daily)
Drug: Vitamin C 500 MG Oral Capsule(Low-dose 1g daily)

Study type

Interventional

Funder types

Other

Identifiers

NCT06074367
Vitamin C in POAF prevention

Details and patient eligibility

About

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.

Enrollment

180 patients

Sex

All

Ages

50 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

180 participants in 3 patient groups, including a placebo group

GROUP 1 (2g Vitamin C )
Experimental group
Treatment:
Drug: Vitamin C 500 MG Oral Capsule(High dose 2g daily)
GROUP 2 (1g Vitamin C )
Experimental group
Treatment:
Drug: Vitamin C 500 MG Oral Capsule(Low-dose 1g daily)
Control group
Placebo Comparator group
Treatment:
Drug: placebo capsules

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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