Clinical trial NCT00665015: Pleural Effusion Following Cardiac Surgery: Prevalence, Risk Factors and Clinical Features
Official title: Pleural Effusions Following Cardiac Surgery: Prevalence, Risk Factors and Clinical Features.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pleural Effusion
Coronary Artery Bypass
Keywords: pleural effusion
coronary artery bypass
heart valve replacement
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2008-04-23
Enrollment: 2892
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing coronary artery bypass grafting surgery, heart valve replacement surgery or both procedures.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Coronary artery bypass grafting (CABG)
* Valve replacement
* Combined CABG and valve replacement
* between January 1st, 2004 and December 31st, 2005

Exclusion Criteria:

* Previous CABG
* Pulmonary and/or aortic artery surgery
* Heart or lung transplant
* Pleural effusion present at the time of surgery

Primary outcomes:
measure: Pleural effusion requiring therapeutic drainage
timeFrame: within the first 12 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Unité de Recherche en Pneumologie, Hôpital Laval
state: Quebec
Study officials:
affiliation: Unité de Recherche en Pneumologie, Hôpital Laval
name: Louis-Philippe Boulet, MD, FRCP(C)
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.