Clinical trial NCT06074367: The Impact of Oral Vitamin C in Prevention for Post Operative Atrial Fibrillation (POAF) in Coronary Artery Bypass Surgery (CABG) Patients
Official title: Post Operative Atril Fibrillation : The Impact of Oral Vitamin C in Reducing the Risk in Egyptian CABG Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Post Operative Atrial Fibrillation
Lead sponsor: Helwan University
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 180
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Postoperative atrial fibrillation (POAF) incidence in patients undergoing coronary artery bypass (CABG) surgery through the administration of vitamin C supplementation compared to placebo group
timeFrame: through hospital stay , an average of 7 days
measure: compare between high dose verses low dose of vitaminC
timeFrame: through hospital stay, an average of 7 days
Secondary outcomes:
measure: Lenght of hospital stay
timeFrame: through hospital stay, an average of 7 days
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: El Sheik Zayed Specialized Hospital
Study officials:
References: