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

April 21, 2008 updated by: Laval University

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

2892

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Québec, Quebec, Canada, G1V4G5
        • Unité de Recherche en Pneumologie, Hôpital Laval

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing coronary artery bypass grafting surgery, heart valve replacement surgery or both procedures.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pleural effusion requiring therapeutic drainage
Time Frame: within the first 12 months after surgery
within the first 12 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Investigators

  • Principal Investigator: Louis-Philippe Boulet, MD, FRCP(C), Unité de Recherche en Pneumologie, Hôpital Laval

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

April 21, 2008

First Submitted That Met QC Criteria

April 21, 2008

First Posted (Estimate)

April 23, 2008

Study Record Updates

Last Update Posted (Estimate)

April 23, 2008

Last Update Submitted That Met QC Criteria

April 21, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEFCS-summer 07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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