Chylothorax Following Heart Surgery

Chylothorax Clinical Trial

Official title:

Chylothorax in Children Following Congenital Heart Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00215098
• Other study ID #: 05-093
• Status: Terminated
• Phase: N/A
• First received: September 20, 2005
• Last updated: March 14, 2012
• Start date: May 2005
• Est. completion date: November 2006

Study information

• Verified date: June 2007
• Source: Children's Healthcare of Atlanta
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 70
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients in the congenital surgery database

• patients have developed post-operative chylous effusions

Exclusion Criteria:

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Chylothorax

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta at Egleston	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Children's Healthcare of Atlanta

Country where clinical trial is conducted

United States,