Trial record 2 of 4 for:    Open Studies | "Pericardial Effusion"

Pleural and Pericardial Effusion Following Open Heart Surgery (IMAGING)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Aarhus University Hospital Skejby
Sponsor:
Information provided by (Responsible Party):
Laura Sommer Hansen, Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier:
NCT02045641
First received: January 21, 2014
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

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 heart 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 heart-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.


Condition Intervention
Heart Disease
Pleural Effusion
Pericardial Effusion
Procedure: pleuracentesis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Clinical Impact of an Aggressive Approach Towards Pleural and Pericardial Effusions Following Open Heart Surgery: a Step Towards Standard Guidelines

Resource links provided by NLM:


Further study details as provided by Aarhus University Hospital Skejby:

Primary Outcome Measures:
  • change in walking distance before and after intervention [ Time Frame: day 4, day 15, day 30 ] [ Designated as safety issue: No ]
    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 [ Time Frame: day 0 and day 30 ] [ Designated as safety issue: No ]
    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)


Other Outcome Measures:
  • needle pleuracentesis versus pigtail catheter [ Time Frame: day 0, day 4, day 15 and day 30 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 150
Study Start Date: September 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02045641

Contacts
Contact: Vibeke E. Hjortdal, MD DMSc PhD vibehjor@rm.dk

Locations
Denmark
Aarhus University Hospital Recruiting
Aarhus N, Denmark, 8200
Contact: Laura Sommer Hansen, MD, PhD fellow    +45 78451199    laurhans@rm.dk   
Principal Investigator: Laura Sommer Hansen, MD, PhD fellow         
Sponsors and Collaborators
Aarhus University Hospital Skejby
Investigators
Study Director: Vibeke E. Hjortdal, MD PHD DMSc Aarhus University Hospital
  More Information

No publications provided

Responsible Party: Laura Sommer Hansen, MD PHD fellow, Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier: NCT02045641     History of Changes
Other Study ID Numbers: 1-10-72-246-13
Study First Received: January 21, 2014
Last Updated: January 23, 2014
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Aarhus University Hospital Skejby:
cardiac surgery
postoperative treatment
pleural effusion
physical performance

Additional relevant MeSH terms:
Heart Diseases
Pericardial Effusion
Pleural Effusion
Cardiovascular Diseases
Pleural Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014