NCT02045641

Pleural and Pericardial Effusion Following Open Heart Surgery

The Clinical Impact of an Aggressive Approach Towards Pleural and Pericardial Effusions Following Open Heart Surgery: a Step Towards Standard Guidelines

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Aarhus University Hospital Skejby · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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: 1. 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. 2. 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: A randomised controlled intervention trial. Patients admitted for open cardiac surgery (aortic valve surgery, coronary artery bypass graft surgery and combinations) will be randomised into either an intervention group or a control group. The intervention group will be followed with physical tests and ultrasonic examination the month following surgery. Pleural or pericardial effusion of a predefined size will be drained. The control group will follow the current postoperative regimen.

Conditions

• Heart Disease
• Pleural Effusion
• Pericardial Effusion

Interventions

Type	Name	Description
PROCEDURE	pleuracentesis	Direct needle drainage of pleural effusions with dynamic ultrasound technique

Timeline

• Start date: 2013-09-01
• Primary completion: 2015-10-01
• Completion: 2015-11-01
• First posted: 2014-01-27
• Last updated: 2015-11-17

Locations

1 site across 1 country: Denmark