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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00665015
First Posted: April 23, 2008
Last Update Posted: April 23, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Laval University
  Purpose
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.

Condition
Pleural Effusion Coronary Artery Bypass

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Pleural Effusions Following Cardiac Surgery: Prevalence, Risk Factors and Clinical Features.

Resource links provided by NLM:


Further study details as provided by Laval University:

Primary Outcome Measures:
  • Pleural effusion requiring therapeutic drainage [ Time Frame: within the first 12 months after surgery ]

Enrollment: 2892
Study Start Date: January 2004
Study Completion Date: October 2006
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing coronary artery bypass grafting surgery, heart valve replacement surgery or both procedures.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00665015


Locations
Canada, Quebec
Unité de Recherche en Pneumologie, Hôpital Laval
Québec, Quebec, Canada, G1V4G5
Sponsors and Collaborators
Laval University
Investigators
Principal Investigator: Louis-Philippe Boulet, MD, FRCP(C) Unité de Recherche en Pneumologie, Hôpital Laval
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Louis-Philippe Boulet, Respirologist, Unité de Recherche en Pneumologie, Hôpital Laval
ClinicalTrials.gov Identifier: NCT00665015     History of Changes
Other Study ID Numbers: PEFCS-summer 07
First Submitted: April 21, 2008
First Posted: April 23, 2008
Last Update Posted: April 23, 2008
Last Verified: April 2008

Keywords provided by Laval University:
pleural effusion
coronary artery bypass
heart valve replacement

Additional relevant MeSH terms:
Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases