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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

Primary Purpose

Post Operative Atrial Fibrillation

Status
Active
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Vitamin C 500 MG Oral Capsule(High dose 2g daily)
Vitamin C 500 MG Oral Capsule(Low-dose 1g daily)
placebo capsules
Sponsored by
Helwan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Operative Atrial Fibrillation

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • El Sheik Zayed Specialized Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

GROUP 1 (2g Vitamin C )

GROUP 2 (1g Vitamin C )

Control group

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Lenght of hospital stay
Estimate the impact of of perioperative oral vitamin C supplementation on hospital length of stay following elective on-pump CABG surgery in old adult Egyptian patients.

Full Information

First Posted
August 25, 2023
Last Updated
October 7, 2023
Sponsor
Helwan University
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1. Study Identification

Unique Protocol Identification Number
NCT06074367
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 13, 2020 (Actual)
Primary Completion Date
October 15, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helwan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Atrial Fibrillation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
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
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GROUP 1 (2g Vitamin C )
Arm Type
Experimental
Arm Title
GROUP 2 (1g Vitamin C )
Arm Type
Experimental
Arm Title
Control group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Vitamin C 500 MG Oral Capsule(High dose 2g daily)
Intervention Description
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
Intervention Name(s)
Vitamin C 500 MG Oral Capsule(Low-dose 1g daily)
Intervention Description
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
Intervention Name(s)
placebo capsules
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative atrial fibrillation (POAF) incidence in patients undergoing coronary artery bypass (CABG) surgery through the administration of vitamin C supplementation compared to placebo group
Description
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.
Time Frame
through hospital stay , an average of 7 days
Title
compare between high dose verses low dose of vitaminC
Description
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.
Time Frame
through hospital stay, an average of 7 days
Secondary Outcome Measure Information:
Title
Lenght of hospital stay
Description
Estimate the impact of of perioperative oral vitamin C supplementation on hospital length of stay following elective on-pump CABG surgery in old adult Egyptian patients.
Time Frame
through hospital stay, an average of 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
El Sheik Zayed Specialized Hospital
City
Giza
ZIP/Postal Code
3210001
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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