Post Operative Atrial FibrillationPhase 4NCT06074367
The Impact of Oral Vitamin C in Prevention for Post Operative Atrial Fibrillation (POAF) in Coronary Artery Bypass Surgery (CABG) Patients
A Phase 4 study testing Vitamin C 500 MG Oral Capsule(High dose 2g daily) and Vitamin C 500 MG Oral Capsule(Low-dose 1g daily) in people with Post Operative Atrial Fibrillation, run by Helwan University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Post Operative Atrial Fibrillation
- What is being tested?
- Vitamin C 500 MG Oral Capsule(High dose 2g daily) and Vitamin C 500 MG Oral Capsule(Low-dose 1g daily)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Oct 2020to 30 Oct 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Post Operative Atril Fibrillation : The Impact of Oral Vitamin C in Reducing the Risk in Egyptian CABG Patients
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.
Read more
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
- Being tested
- Vitamin C 500 MG Oral Capsule(High dose 2g daily), Vitamin C 500 MG Oral Capsule(Low-dose 1g daily), placebo capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin C 500 MG Oral Capsule(High dose 2g daily)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
Vitamin C 500 MG Oral Capsule(Low-dose 1g daily)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.
placebo capsulesDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| GROUP 1 (2g Vitamin C ) | Experimental | Not described Receives: Drug: Vitamin C 500 MG Oral Capsule(High dose 2g daily) |
| GROUP 2 (1g Vitamin C ) | Experimental | Not described Receives: Drug: Vitamin C 500 MG Oral Capsule(Low-dose 1g daily) |
| Control group | Placebo comparator | Not described Receives: Drug: placebo capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through hospital stay , an average of 7 days
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.
Measured: through hospital stay, an average of 7 days
Secondary outcomes (1)
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.
Measured: through hospital stay, an average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start13 Oct 2020
- Primary completion15 Oct 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sahar Mohamed Hesham, Helwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06074367
- Sponsor's protocol ID
- Vitamin C in POAF prevention
- Status last verified
- Oct 2023
- First submitted
- 25 Aug 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Operative Atril Fibrillation : The Impact of Oral Vitamin C in Reducing the Risk in Egyptian CABG Patients
- ClinicalTrials.gov ID
- NCT06074367
- Acronym / sponsor ID
- Vitamin C in POAF prevention
- Conditions
- Post Operative Atrial Fibrillation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Study start
- 13 Oct 2020 (actual)
- Primary completion
- 15 Oct 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GROUP 1 (2g Vitamin C ) | Experimental | Drug: Vitamin C 500 MG Oral Capsule(High dose 2g daily) |
| GROUP 2 (1g Vitamin C ) | Experimental | Drug: Vitamin C 500 MG Oral Capsule(Low-dose 1g daily) |
| Control group | Placebo comparator | Drug: placebo capsules |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | GROUP 1 (2g Vitamin C ) |
| 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. | Drug | GROUP 2 (1g Vitamin C ) |
| placebo capsulesA 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. | Drug | Control group |
Primary outcome
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.
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.
1 secondary outcome
Lenght of hospital stay
Time frame: through hospital stay, an average of 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin C 500 MG Oral Capsule(High dose 2g daily) and Vitamin C 500 MG Oral Capsule(Low-dose 1g daily) in people with Post Operative Atrial Fibrillation, run by Helwan University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: through hospital stay , an average of 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.