Pleural EffusionNCT00665015
Pleural Effusion Following Cardiac Surgery: Prevalence, Risk Factors and Clinical Features
An observational study of Pleural Effusion and Coronary Artery Bypass, run by Laval University at 1 site in Canada.
Trial summary
Pleural effusion is a common complication of cardiac surgery. The aim of this study was to determine the prevalence, characteristics and determinants of clinically significant pleural effusions, defined as those requiring therapeutic pleural drainage. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pleural Effusion, Coronary Artery Bypass
- How many people
- 2,892 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2004to Oct 2006
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing coronary artery bypass grafting surgery, heart valve replacement surgery or both procedures.
Who may be able to join
- Coronary artery bypass grafting (CABG)
- Valve replacement
- Combined CABG and valve replacement
- between January 1st, 2004 and December 31st, 2005
Who cannot join
- Previous CABG
- Pulmonary and/or aortic artery surgery
- Heart or lung transplant
- Pleural effusion present at the time of surgery
Trial locations and contacts
1 site in 1 country.
Canada1 site
Unité de Recherche en Pneumologie, Hôpital Laval
Québec, Quebec, G1V4G5
About this study
Official title: Pleural Effusions Following Cardiac Surgery: Prevalence, Risk Factors and Clinical Features.
Pleural effusion is a common complication of cardiac surgery. The aim of this study was to determine the prevalence, characteristics and determinants of clinically significant pleural effusions, defined as those requiring therapeutic pleural drainage.
Read the detailed description
This was a retrospective cohort study of prevalence and characteristics of patients who had a pleural effusion after coronary artery bypass graft, valve replacement or both procedures.
Information was collected on all consecutive patients who underwent CABG surgery and/or valve replacement between January 1, 2004 and December 31, 2005. Demographic information, anthropometric parameters, cardiac and renal function assessments, and comorbid conditions were retrieved from medical files. We also collected data on the type of procedure, whether it was elective or urgent, the number and origin of the grafts, the duration of surgery and of cardiopulmonary bypass and the postoperative complications, including pleural effusions. Clinical presentation and evolution of the effusions as well as pleural fluid characteristics were also studied.
Patients were considered to have a clinically significant pleural effusion when they met at least one of the following criteria: need for thoracentesis, a pleural drainage tube or a hospital readmission due to a pleural effusion that occurred within one year of surgery.
- Conditions
- Pleural Effusion, Coronary Artery Bypass
- Keywords
- pleural effusion, coronary artery bypass, heart valve replacement
- Medical subject headings
- Pleural Effusion
What is being measured
The primary outcome is the main question the study is designed to answer.
Pleural effusion requiring therapeutic drainage
Measured: within the first 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2008 (estimated)
- Study startJan 2004
- Primary completionDec 2005
- Study completionOct 2006
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 Pleural EffusionStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,892 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Investigators
- Louis-Philippe Boulet, MD, FRCP(C), Principal investigator, Unité de Recherche en Pneumologie, Hôpital Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00665015
- Sponsor's protocol ID
- PEFCS-summer 07
- Status last verified
- Apr 2008
- First submitted
- 21 Apr 2008
- Last updated
- 23 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Labidi M, Baillot R, Dionne B, Lacasse Y, Maltais F, Boulet LP. Pleural effusions following cardiac surgery: prevalence, risk factors, and clinical features. Chest. 2009 Dec;136(6):1604-1611. doi: 10.1378/chest.09-0689. Epub 2009 Jul 6.
PubMed 19581352
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pleural Effusions Following Cardiac Surgery: Prevalence, Risk Factors and Clinical Features.
- ClinicalTrials.gov ID
- NCT00665015
- Acronym / sponsor ID
- PEFCS-summer 07
- Conditions
- Pleural Effusion, Coronary Artery Bypass
- Keywords
- pleural effusion, coronary artery bypass, heart valve replacement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,892 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Dec 2005 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 23 Apr 2008 (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.
Pleural effusion is a common complication of cardiac surgery. The aim of this study was to determine the prevalence, characteristics and determinants of clinically significant pleural effusions, defined as those requiring therapeutic pleural drainage.
Detailed description
This was a retrospective cohort study of prevalence and characteristics of patients who had a pleural effusion after coronary artery bypass graft, valve replacement or both procedures.
Information was collected on all consecutive patients who underwent CABG surgery and/or valve replacement between January 1, 2004 and December 31, 2005. Demographic information, anthropometric parameters, cardiac and renal function assessments, and comorbid conditions were retrieved from medical files. We also collected data on the type of procedure, whether it was elective or urgent, the number and origin of the grafts, the duration of surgery and of cardiopulmonary bypass and the postoperative complications, including pleural effusions. Clinical presentation and evolution of the effusions as well as pleural fluid characteristics were also studied.
Patients were considered to have a clinically significant pleural effusion when they met at least one of the following criteria: need for thoracentesis, a pleural drainage tube or a hospital readmission due to a pleural effusion that occurred within one year of surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing coronary artery bypass grafting surgery, heart valve replacement surgery or both procedures.
Key inclusion criteria (4 listed)
- Coronary artery bypass grafting (CABG)
- Valve replacement
- Combined CABG and valve replacement
- between January 1st, 2004 and December 31st, 2005
Key exclusion criteria (4 listed)
- Previous CABG
- Pulmonary and/or aortic artery surgery
- Heart or lung transplant
- Pleural effusion present at the time of surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pleural effusion requiring therapeutic drainage
Time frame: within the first 12 months after surgery
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 23 Apr 2008.
- Derived from this study: PubMed 19581352Labidi M, Baillot R, Dionne B, Lacasse Y, Maltais F, Boulet LP. Pleural effusions following cardiac surgery: prevalence, risk factors, and clinical features. Chest. 2009 Dec;136(6):1604-1611. doi: 10.1378/chest.09-0689. Epub 2009 Jul 6.
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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.
Louis-Philippe Boulet, MD, FRCP(C) principal investigator
Unité de Recherche en Pneumologie, Hôpital Laval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pleural Effusion and Coronary Artery Bypass, run by Laval University at 1 site in Canada.
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 4 inclusion and 4 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 23 Apr 2008. 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 Canada. 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?
Pleural effusion requiring therapeutic drainage (time frame: within the first 12 months after surgery). 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 NCT00665015, 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 23 Apr 2008.