Pleural and Pericardial Effusion Following Open Heart Surgery

Heart Disease Clinical Trial

— IMAGING  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02045641
• Other study ID #: 1-10-72-246-13
• Status: Completed
• Phase: N/A
• First received: January 21, 2014
• Last updated: November 16, 2015
• Start date: September 2013
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: Aarhus University Hospital Skejby
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Disease
• Pericardial Effusion
• Pleural Effusion

Intervention

Procedure:
• pleuracentesis
Direct needle drainage of pleural effusions with dynamic ultrasound technique

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus N

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital Skejby

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	needle pleuracentesis versus pigtail catheter	To asses how much of the pleural effusion is drained when performing needle puncture instead of inserting a pigtail catheter. Secondary to compare the complication rate of the two procedures.	day 0, day 4, day 15 and day 30	Yes
Primary	change in walking distance before and after intervention	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%.	day 4, day 15, day 30	No
Secondary	change in walking distance from baseline to day 30 after surgery	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)	day 0 and day 30	No