Pleural Effusion Following Cardiac Surgery: Prevalence, Risk Factors and Clinical Features

Pleural Effusion Clinical Trial

Official title:

Pleural Effusions Following Cardiac Surgery: Prevalence, Risk Factors and Clinical Features.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00665015
• Other study ID #: PEFCS-summer 07
• Status: Completed
• Phase: N/A
• First received: April 21, 2008
• Last updated: April 21, 2008
• Start date: January 2004
• Est. completion date: October 2006

Study information

• Verified date: April 2008
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2892
• Est. completion date: October 2006
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Coronary Artery Bypass
• Pleural Effusion

Locations

Country	Name	City	State
Canada	Unité de Recherche en Pneumologie, Hôpital Laval	Québec	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pleural effusion requiring therapeutic drainage		within the first 12 months after surgery	No