CTRI/2020/04/024511尚未招募Phase 3 4
Efficacy of amiodarone in patient with pre-existing atrial fibrillation and evaluating re-emergence of atrial fibrillation after aortic cross-clamp release in open heart surgery.
VMMC AND SAFDARJUNG HOSPITAL1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年9月4日最近更新:
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- 1 To investigate whether prophylactic amiodarone infusion prevents re-emergent of atrial fibrillation after aortic cross-clamp removed in patients with atrial fibrillation undergoing open cardiac surgery.
研究概览
简要总结
as atrial fibrillation is the major event in cardiac surgery which lead to hemodynamic instability so this trial will help to recude the atrial fibrilation in cardiac patient
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •All adult patient with valvular heart surgery/cabg with atrial fibrillation.
排除标准
- •Contraindications to amiodarone (sick sinus syndrome, atrioventricular conduction abnormalities, thyroid disease, interstitial lung disorders, renal or liver disease) b) Need of concomitant cardiac surgical procedure c)Emergency operation d)Pretreatment with digoxin or amiodarone .
结局指标
主要结局
1 To investigate whether prophylactic amiodarone infusion prevents re-emergent of atrial fibrillation after aortic cross-clamp removed in patients with atrial fibrillation undergoing open cardiac surgery.
时间窗: Immediately after aortic cross-clamp release and end of surgery
3.2To study the hemodynamic response of amiadarone after clamp off.
时间窗: Immediately after aortic cross-clamp release and end of surgery
3.3Ease of separation from cardiopulmonary bypass.
时间窗: Immediately after aortic cross-clamp release and end of surgery
次要结局
- .To study the hemodynamic response of amiadarone after clamp off.(.Ease of separation from cardiopulmonary bypass)
研究者
研究点 (1)
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