Heart DiseaseIMAGINGNCT02045641
Pleural and Pericardial Effusion Following Open Heart Surgery
A study testing pleuracentesis in people with Heart Disease and Pleural Effusion, run by Aarhus University Hospital Skejby at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Disease, Pleural Effusion, Pericardial Effusion
- What is being tested?
- pleuracentesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2013to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Clinical Impact of an Aggressive Approach Towards Pleural and Pericardial Effusions Following Open Heart Surgery: a Step Towards Standard Guidelines
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.
Read the 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.
- Conditions
- Heart Disease, Pleural Effusion, Pericardial Effusion
- Being tested
- pleuracentesis
- Keywords
- cardiac surgery, postoperative treatment, pleural effusion, physical performance
- Medical subject headings
- Heart Diseases, Pleural Effusion, Pericardial Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pleuracentesisProcedure or surgery
Direct needle drainage of pleural effusions with dynamic ultrasound technique
| Study group | Role | What they receive |
|---|---|---|
| current postoperative regimen | No intervention | 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. |
| pleuracentesis | Experimental | 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. Receives: Procedure: pleuracentesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: day 4, day 15, day 30
Secondary outcomes (1)
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)
Measured: day 0 and day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2014 (estimated)
- Study startSep 2013
- Primary completionOct 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital Skejby
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Sommer Hansen, Aarhus University Hospital Skejby
- Investigators
- Vibeke E. Hjortdal, MD PHD DMSc, Study director, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02045641
- Sponsor's protocol ID
- 1-10-72-246-13
- Acronym
- IMAGING
- Status last verified
- Nov 2015
- First submitted
- 21 Jan 2014
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27401709
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Impact of an Aggressive Approach Towards Pleural and Pericardial Effusions Following Open Heart Surgery: a Step Towards Standard Guidelines
- ClinicalTrials.gov ID
- NCT02045641
- Acronym / sponsor ID
- IMAGING / 1-10-72-246-13
- Conditions
- Heart Disease, Pleural Effusion, Pericardial Effusion
- Keywords
- cardiac surgery, postoperative treatment, pleural effusion, physical performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Aarhus University Hospital SkejbyUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 27 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| current postoperative regimen | No intervention | –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. |
| pleuracentesis | Experimental | Procedure: pleuracentesisThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pleuracentesisDirect needle drainage of pleural effusions with dynamic ultrasound technique | Procedure or surgery | pleuracentesis |
Primary outcome
change in walking distance before and after intervention
Time frame: day 4, day 15, day 30
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%.
1 secondary outcome
change in walking distance from baseline to day 30 after surgery
Time frame: day 0 and day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2015.
- Derived from this study: PubMed 27401709Hansen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vibeke E. Hjortdal, MD PHD DMSc study director
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pleuracentesis in people with Heart Disease and Pleural Effusion, run by Aarhus University Hospital Skejby at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in walking distance before and after intervention (time frame: day 4, day 15, day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02045641, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2015.