Chylothorax Following Heart Surgery

This study has been terminated.
(insufficient data)
Sponsor:
Information provided by:
Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier:
NCT00215098
First received: September 20, 2005
Last updated: March 14, 2012
Last verified: June 2007
  Purpose

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.


Condition
Chylothorax

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Chylothorax in Children Following Congenital Heart Surgery

Resource links provided by NLM:


Further study details as provided by Children's Healthcare of Atlanta:

Estimated Enrollment: 70
Study Start Date: May 2005
Study Completion Date: November 2006
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients in the congenital surgery database

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

  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: NCT00215098

Locations
United States, Georgia
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Children's Healthcare of Atlanta
Investigators
Principal Investigator: Brian Kogon, MD Emory University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00215098     History of Changes
Other Study ID Numbers: 05-093
Study First Received: September 20, 2005
Last Updated: March 14, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Healthcare of Atlanta:
pediatric health
cardiac
congenital heart surgery
post-operative chylous effusions
heart defects
children

Additional relevant MeSH terms:
Chylothorax
Pleural Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 01, 2014