Post Operative Atrial Fibrillation: Alleviation by Calcium Chloride Injection Into Cardiac Ganglionic Plexus During Coronary Artery Bypass Grafting.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in number of patients who developed Atrial fibrillation
研究概览
简要总结
This study hypothesize that injecting calcium chloride (CaCl2) into the major atrial ganglionated plexus (GPs) during on pump Coronary artery bypass graft (CABG) can reduce the incidence of Post operative Atrial fibrillation in the first 7 days after surgery.The study is designed to be prospective interventional study two armed RCT for on pump CABG patient.
The intervention arm will be injected with Calcium chloride in the four major atrial ganglionic plexus The control arm will be injected with sodium chloride to determine the effect of Calcium chloride on Post CABG Atrial fibrillation
详细描述
This study hypothesize that injecting calcium chloride into the major atrial ganglionic plexus (GPs) during On pump Coronary artery bypass graft (CABG) can reduce the incidence of Post operative Atrial fibrillation by calcium-induced autonomic neurotoxicity, the incidence of Post operative Atrial fibrillation can be reduced by suppressing the function of the major atrial GPs and the surrounding neural network that play an important role in initiating Post operative Atrial fibrillation. The study is designed to be prospective interventional study two armed RCT for on pump CABG patient. The plan of work will include dividing the patients into 2 randomized control groups In the intervention group patients will be injected with 5% Calcium chloride in the 4 Major atrial ganglionic plexus The other arm will be Coronary artery bypass graft patients who will be injected with sodium chloride 0.9% to compare the two groups to evaluate to evaluate the effect of Calcium chloride in post CABG atrial fibrillation between the 2 arms of the study.
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
- None
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients more than 18 years old 2 ) patients undergoing On pump CABG
排除标准
- •patients >75 years of age
- •Patients with Pre operative Atrial fibrillation
- •Patients with Significant valvular disease
- •Ejection fraction <30%
- •Combined surgery of any kind
- •Congenital heart disease
- •Abnormal severe liver or kidney dysfunction.
- •Patients undergoing Off-pump CABG
- •Poorly controlled hyperthyroidism
- •Refusal to enrollment.
研究组 & 干预措施
Calcium chloride injection in ganglionated plexis for Atrial Fibrillation alleviation post CABG
The Patients in the intervention arm will be injected with Calcium chloride in the 4 major atrial ganglionated plexis after the by pass is completed.
干预措施: Calcium Chloride (Drug)
patients who will receive their regular standard of care without calcium chloride injection
A group of patients who will undergo Coronary artery bypass graft surgery will be injected with normal saline in the ganglionic Plexus during Coronary artery bypass graft to act as a comparator to determine if calcium chloride injection alleviate Atrial fibrillation post surgery
干预措施: Sodium Chloride 0.9% Inj (Drug)
结局指标
主要结局
Change in number of patients who developed Atrial fibrillation
时间窗: Up to one week from the time of surgery determined by serial ECGs per day
Compare if calcium chloride injection decrease the percentage of patients who developed Atrial fibrillation in intervention group with those in placebo group
次要结局
- Change in length of hospital stay(Up to the time of patient discharge from the hospital (from the time of post Coronary artery bypass graft surgery))
研究者
Nadine Osama Elgarhi
Doctor of pharmacy
Helwan University