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

This study has been completed.
Sponsor:
Information provided by:
Laval University
ClinicalTrials.gov Identifier:
NCT00665015
First received: April 21, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted
  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 ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Laval University

Additional 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
Study First Received: April 21, 2008
Last Updated: April 21, 2008
Health Authority: Canada: Canadian Institutes of Health Research

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

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

ClinicalTrials.gov processed this record on July 24, 2014