Clinical trial NCT02045641: Pleural and Pericardial Effusion Following Open Heart Surgery
Official title: The Clinical Impact of an Aggressive Approach Towards Pleural and Pericardial Effusions Following Open Heart Surgery: a Step Towards Standard Guidelines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Disease
Pleural Effusion
Pericardial Effusion
Keywords: cardiac surgery
postoperative treatment
pleural effusion
physical performance
Lead sponsor: Aarhus University Hospital Skejby
Sponsor class: OTHER
First posted: 2014-01-27
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: change in walking distance before and after intervention
timeFrame: day 4, day 15, day 30
Secondary outcomes:
measure: change in walking distance from baseline to day 30 after surgery
timeFrame: day 0 and day 30
Other outcomes:
measure: needle pleuracentesis versus pigtail catheter
timeFrame: day 0, day 4, day 15 and day 30
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Vibeke E. Hjortdal, MD PHD DMSc
role: STUDY_DIRECTOR
References:
citation: 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.