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Clinical Trials/NCT06074367
NCT06074367
Active, not recruiting
Phase 4

Post Operative Atril Fibrillation : The Impact of Oral Vitamin C in Reducing the Risk in Egyptian CABG Patients

Helwan University1 site in 1 country180 target enrollmentOctober 13, 2020

Overview

Phase
Phase 4
Intervention
Vitamin C 500 MG Oral Capsule(High dose 2g daily)
Conditions
Post Operative Atrial Fibrillation
Sponsor
Helwan University
Enrollment
180
Locations
1
Primary Endpoint
compare between high dose verses low dose of vitaminC
Status
Active, not recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 13, 2020
End Date
October 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sahar Mohamed Hesham

principle investigator

Helwan University

Eligibility Criteria

Inclusion Criteria

  • Not provided

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.

Arms & Interventions

GROUP 1 (2g Vitamin C )

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

GROUP 2 (1g Vitamin C )

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

Control group

Intervention: placebo capsules

Outcomes

Primary Outcomes

compare between high dose verses low dose of vitaminC

Time Frame: through hospital stay, an average of 7 days

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.

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

Time Frame: through hospital stay , an average of 7 days

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.

Secondary Outcomes

  • Lenght of hospital stay(through hospital stay, an average of 7 days)

Study Sites (1)

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