Pleural and Pericardial Effusion Following Open Heart Surgery (IMAGING)

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Disease; Pleural Effusion; Pericardial Effusion
• Intervention / Treatment: Procedure: pleuracentesis

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.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus N, Denmark, 8200
    • Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: current postoperative regimen; The group will follow the current postoperative regimen at the surgical ward; screening for pleural effusions with x-ray and further diagnostic procedures in case of symptoms. Treatment will be entirely in the hands of the clinical personnel.
Experimental: pleuracentesis; The group will follow the current postoperative regimen. In addition they will be followed with ultrasound examination, clinical examination, spirometry examination and 6 minute walk test. In case of either a) pleural effusion > 400ml OR b) pleural effusion< 400ml with symptoms in rest or during the walk test, the effusion will be drained and examinations will be repeated. In case of pericardial effusion of predefined size and location, either the surgeon on call or a cardiologist will be consulted.	Procedure: pleuracentesis; Direct needle drainage of pleural effusions with dynamic ultrasound technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Aarhus University Hospital Skejby
• Investigators: Study Director: Vibeke E. Hjortdal, MD PHD DMSc, Aarhus University Hospital

Publications and helpful links

General Publications

• Hansen LS, Hjortdal VE, Jakobsen CJ, Heiberg J, Maagaard M, Sloth E. Early, dedicated follow-up and treatment of pleural effusions enhance the recovery rate after open cardiac surgery: results from a randomized, clinical trial. Eur J Cardiothorac Surg. 2017 Jan;51(1):58-66. doi: 10.1093/ejcts/ezw233. Epub 2016 Jul 11.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: January 21, 2014
• First Submitted That Met QC Criteria: January 23, 2014
• First Posted (Estimate): January 27, 2014

Study Record Updates

• Last Update Posted (Estimate): November 17, 2015
• Last Update Submitted That Met QC Criteria: November 16, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: cardiac surgery; physical performance; pleural effusion; postoperative treatment
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Respiratory Tract Diseases; Pleural Diseases; Heart Diseases; Pleural Effusion; Pericardial Effusion
• Other Study ID Numbers: 1-10-72-246-13