Chylothorax Following Heart Surgery

March 14, 2012 updated by: Children's Healthcare of Atlanta

Chylothorax in Children Following Congenital Heart Surgery

The purpose of this study is to determine at risk populations for certain congenital heart defects or certain operative procedures and to define the associated morbidity secondary to chylothorax - prolonged chest tube drainage, prolonged hospital stay, need for central access and hyperalimentation, subsequent infection.

Study Overview

Status

Terminated

Conditions

Detailed Description

Chylothorax is not uncommon following congenital heart surgery. It often results in prolonged chest tube drainage and hospital stays. Due to the feeding difficulties, it often results in malnutrition and the need for central hyperalimentation. In addition, it results in a depressed immune system with the possibility of subsequent infection. Chylothorax can be a significant contributor to post-operative morbidity and mortality.

The primary aims are to determine at risk populations - certain congenital heart defects or certain operative procedures, to define the associated morbidity secondary to chylothorax - prolonged chest tube drainage, prolonged hospital stay, need for central access and hyperalimentation, subsequent infection and to review our current treatment methods - change formulas, hyperalimentation, somatostatin. The secondary aims are to determine ways to prevent chylothorax, determine the most successful treatment method, and to discover better treatment methods. This study will be conducted through a retrospective chart review.

Study Type

Observational

Enrollment (Anticipated)

70

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

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Children's Healthcare of Atlanta at Egleston

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 in the congenital surgery database

Description

Inclusion Criteria:

  • Patients in the congenital surgery database
  • patients have developed post-operative chylous effusions

Exclusion Criteria:

-

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

  • Time Perspectives: Retrospective

Collaborators and Investigators

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

Sponsor

Children's Healthcare of Atlanta

Investigators

  • Principal Investigator: Brian Kogon, MD, Emory University

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

May 1, 2005

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

September 20, 2005

First Submitted That Met QC Criteria

September 20, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

March 16, 2012

Last Update Submitted That Met QC Criteria

March 14, 2012

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-093

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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