Influence of Oral Vitamine C Supplementation on the Incidence of Post-operative Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Arrhythmia
研究概览
简要总结
Post-operative atrial fibrillation (POAF) is the most common arrhythmia which typically develops 2-3 days after cardiac surgery. The incidence of POAF variates between 10% and 65% depending on the type of cardiac surgery and is especially high in patients which underwent Coronary Artery Bypass Grafting (CABG) and heart valve surgery. POAF is associated with increased morbidity and mortality and has a major impact on hospital resources.
The precise pathogenesis of POAF is very complex, but several studies have demonstrated an association between inflammation, oxidative stress and POAF. Since this oxidative stress may be reduced by dietary anti-oxidantia such as vitamin C, the aim of this study is to evaluate the effect of oral vitamin C administration of the incidence of POAF.
详细描述
After obtaining informed consent, patients which are planned for CABG or heart valve surgery are randomly assigned into the Vitamin C group or Placebo Group.
Each patient will receive 1 g Vitamin C or Placebo twice a day from 5 days before until 10 days after surgery. The medication will be given orally and both patient and surgeon are blinded for the administrated medication.
Patients receive standard of care in the post-operative period, which includes close monitoring for possible arrhythmias. If such an arrhythmia develops, this is treated according to the normal procedures. All information such as the used medication, the hospitalization / ICU length of stay and the ventilation time is automatically registered in the patient records.
From each patient, three additional blood samples (peri-operative, post-operative Day 0, post-operative Day 1) will be obtained for analysis of Neutrophil gelatinase-associated lipocalin (NGAL), a possible marker of subclinical kidney damage. These samples will be analysed in batch once all samples are collected.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signed informed consent
- •eligible for elective cardiac surgery
- •preoperative sinus rhythm
排除标准
- •patients who do not want to participate
研究组 & 干预措施
Placebo
Placebo as an alternative for Vitamin C tablets
干预措施: Placebo (Other)
Vitamin C
Vitamin C 1000mg PO from 5 days before surgery until 10 days after surgery
干预措施: Vitamin C (Dietary Supplement)
结局指标
主要结局
Arrhythmia
时间窗: First 5 days postoperatively
Incidence
次要结局
- hours of endotracheal ventilation(from arrival at ICU after surgery until the time of discharge from ICU. average 48 hours.)
- Length of stay at ICU(from time of arrival at ICU after surgery until the time of discharge from ICU. upto 14 days. average 48 hours.)
- Length of stay in the hospital(from time of arrival at ICU after surgery until the time of hospital discharge. upto 120 days.)
- Cost of postoperative medication(from time of arrival at ICU after surgery until the time of hospital discharge. upto 120 days)
- subclinical kidney damage(after induction of anesthesia and two hours after CPB)
- Postoperative complications(from time of arrival at ICU until the time of hospital discharge. upto 120 days)
研究者
Dr. Alain Kalmar, MD, PhD
Staff Anesthesist
Algemeen Ziekenhuis Maria Middelares