Clinical Trial: Pleural and Pericardial Effusion Following Open Heart Surgery

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: Aarhus University Hospital Skejby

Current Primary Outcome: change in walking distance before and after intervention [ Time Frame: 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%.


Original Primary Outcome: Same as current

Current Secondary Outcome: change in walking distance from baseline to day 30 after surgery [ Time Frame: day 0 and day 30 ]

The difference in walking distance from before surgery (day 0) to after surgery (day 30) will be compared between the intervention arm (+ pleuracentesis) and the control arm (standard postoperative regimen)


Original Secondary Outcome: Same as current

Information By: Aarhus University Hospital Skejby

Dates:
Date Received: January 21, 2014
Date Started: September 2013
Date Completion:
Last Updated: November 16, 2015
Last Verified: November 2015