Pleural and Pericardial Effusion Following Open Heart Surgery

Study Overview
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Brief Summary
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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
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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: 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.

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

Conditions
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Heart Disease, Pleural Effusion, Pericardial Effusion

Intervention / Treatment
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* Procedure: pleuracentesis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: current postoperative regimen<br>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<br>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<br>* Direct needle drainage of pleural effusions with dynamic ultrasound technique<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac surgery, postoperative treatment, pleural effusion, physical performance