The Clinical Impact of an Aggressive Approach Towards Pleural and Pericardial Effusions Following Open Heart Surgery: a Step Towards Standard Guidelines
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- change in walking distance before and after intervention
研究概览
简要总结
One of the most common postoperative complications after open cardiac surgery is fluid accumulation between the pleural membranes or in the pericardial sac. This study investigates the consequence of such fluid accumulations on physical performance, recovery-time, cardiac and respiratory complications, and quality of life. Half of the participants will be followed closely and offered fluid drainage at a low threshold, and half of the participants will follow the current postoperative regimen.
详细描述
Introduction:
Knowledge concerning the impact of pleural and pericardial effusions on physical performance, recovery-time, cardiac and respiratory complications, and quality of life after open cardiac surgery is scarce. A more aggressive approach towards effusions has been suggested, but further studies are needed.
Objectives:
- to determine the size of pleural and pericardial effusion that results in at least 30% reduction of physical performance in the 6-minute walk test.
- to compare the improvement in physical performance between the intervention group and the control group, measured from baseline to day 30 after surgery.
Materials and methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Age >18 years.
- •Admitted for elective aortic valve surgery, coronary artery bypass graft surgery or combinations.
- •Be able to understand the written and oral patient information and to give informed consent.
排除标准
- •Surgical combinations involving the mitral valve since they are already examined with full echocardiography prior to discharge, which may influence protocol driven decisions.
- •Simultaneous participation in any other clinical intervention trial
结局指标
主要结局
change in walking distance before and after intervention
时间窗: day 4, day 15, day 30
The primary outcome measure is the change in walking distance before and after pleuracentesis, subsequently the size of pleural effusion (both cm measured on ultrasound and drained volume) that results in a reduction of distance in the 6 minute walk test of at least 30%.
次要结局
- change in walking distance from baseline to day 30 after surgery(day 0 and day 30)
研究者
Laura Sommer Hansen
MD PHD fellow
Aarhus University Hospital Skejby