Pleural and Pericardial Effusion Following Open Heart Surgery

NCT ID: NCT02045641

Last Updated: 2015-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2015-11-30

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.

Conditions

Heart Disease; Pleural Effusion; Pericardial Effusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

pleuracentesis

Intervention Type: PROCEDURE

Direct needle drainage of pleural effusions with dynamic ultrasound technique

Interventions

pleuracentesis

Direct needle drainage of pleural effusions with dynamic ultrasound technique

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aarhus University Hospital Skejby

OTHER

Sponsor Role: lead

Responsible Party

Laura Sommer Hansen

MD PHD fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vibeke E. Hjortdal, MD PHD DMSc

Role: STUDY_DIRECTOR

Aarhus University Hospital

Locations

Aarhus University Hospital

Aarhus N, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 27401709 (View on PubMed)

Other Identifiers

1-10-72-246-13

Identifier Type: -

Identifier Source: org_study_id