NCT00724581Unknown4 期
Amiodarone Prophylaxis for Atrial Fibrillation in Patients Undergoing Surgery for Lung Cancer: A Controlled, Randomized, Double Blinded Trial
Aarhus University Hospital1 个研究点 分布在 1 个国家目标入组 275 人开始时间: 2008年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 275
- 试验地点
- 1
- 主要终点
- Free of atrial fibrillation
研究概览
简要总结
Patients undergoing lung resection due to pulmonary cancer can be compromised in their postoperative period due to atrial fibrillation.
A retrospective analysis performed at our institution indicates that 30 % of the population develope atrial fibrillation in the postoperative period.
Amiodarone is known to diminish the occurence of postoperative atrial fibrillation after heart surgery, why this drug is chosen as a prophylactic agent for the mentioned population.
Amiodarone is administrated twice a day for 5 days at a dose of 600 mg oral treatment after an initial loading bolus og 300 mg intravenously.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Resection of the lung due to confirmed diagnosis of cancer pulmones.
- •Elective operation (scheduled operation for at least one day)
- •Ready to be randomized
- •Patient must be at least 18 at time of operation
排除标准
- •Former operation of the lung
- •Former heart surgery
- •Bradycardia below 40 beats/ min
- •Hypotension with systolic blood pressure below 80 mmHg
- •AV-blockage of any degree or sick sinus node
- •QTc interval above 440 ms for men or above 460 ms for women
- •Paroxysmal, persistent or permanent atrial fibrillation or flutter
- •Former atrial fibrillation or flutter for more than a month.
- •Pregnant or positive pregnancy test
- •Breastfeeding
- •ALAT of more than twice the normal over limit
- •Treatment with monoamineoxidase inhibitors (MAOI)
- •Allergy to one or more components in amiodarone
研究组 & 干预措施
A
Experimental
干预措施: Amiodarone (Drug)
结局指标
主要结局
Free of atrial fibrillation
时间窗: 31082009
次要结局
- Cost-benefit analysis of amiodarone prophylactic(31082009)
研究者
研究点 (1)
Loading locations...
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