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Pleural and Pericardial Effusion Following Open Heart Surgery (IMAGING)

Primary Purpose

Heart Disease, Pleural Effusion, Pericardial Effusion

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
pleuracentesis
Sponsored by
Aarhus University Hospital Skejby
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Disease focused on measuring cardiac surgery, postoperative treatment, pleural effusion, physical performance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

current postoperative regimen

pleuracentesis

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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%.

Secondary Outcome Measures

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)

Full Information

First Posted
January 21, 2014
Last Updated
November 16, 2015
Sponsor
Aarhus University Hospital Skejby
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1. Study Identification

Unique Protocol Identification Number
NCT02045641
Brief Title
Pleural and Pericardial Effusion Following Open Heart Surgery
Acronym
IMAGING
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

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital Skejby

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Disease, Pleural Effusion, Pericardial Effusion
Keywords
cardiac surgery, postoperative treatment, pleural effusion, physical performance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
current postoperative regimen
Arm Type
No Intervention
Arm Description
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.
Arm Title
pleuracentesis
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
pleuracentesis
Intervention Description
Direct needle drainage of pleural effusions with dynamic ultrasound technique
Primary Outcome Measure Information:
Title
change in walking distance before and after intervention
Description
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%.
Time Frame
day 4, day 15, day 30
Secondary Outcome Measure Information:
Title
change in walking distance from baseline to day 30 after surgery
Description
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)
Time Frame
day 0 and day 30
Other Pre-specified Outcome Measures:
Title
needle pleuracentesis versus pigtail catheter
Description
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.
Time Frame
day 0, day 4, day 15 and day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vibeke E. Hjortdal, MD PHD DMSc
Organizational Affiliation
Aarhus University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
27401709
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.
Results Reference
derived

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Pleural and Pericardial Effusion Following Open Heart Surgery

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