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临床试验/NCT06074367
NCT06074367进行中(未招募)4 期

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

Helwan University1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2020年10月13日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
进行中(未招募)
入组人数
180
试验地点
1
主要终点
compare between high dose verses low dose of vitaminC

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

盲法说明

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

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 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.

研究组 & 干预措施

GROUP 1 (2g Vitamin C )

Experimental

干预措施: Vitamin C 500 MG Oral Capsule(High dose 2g daily) (Drug)

GROUP 2 (1g Vitamin C )

Experimental

干预措施: Vitamin C 500 MG Oral Capsule(Low-dose 1g daily) (Drug)

Control group

Placebo Comparator

干预措施: placebo capsules (Drug)

结局指标

主要结局

compare between high dose verses low dose of vitaminC

时间窗: 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

时间窗: 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.

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sahar Mohamed Hesham

principle investigator

Helwan University

研究点 (1)

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