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Chylothorax Following Heart Surgery

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.
 
ClinicalTrials.gov Identifier: NCT00215098
Recruitment Status : Terminated (insufficient data)
First Posted : September 22, 2005
Last Update Posted : March 16, 2012
Sponsor:
Information provided by:
Children's Healthcare of Atlanta

Tracking Information
First Submitted Date September 20, 2005
First Posted Date September 22, 2005
Last Update Posted Date March 16, 2012
Study Start Date May 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00215098 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Chylothorax Following Heart Surgery
Official Title Chylothorax in Children Following Congenital Heart Surgery
Brief 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.
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
Study Design Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients in the congenital surgery database
Condition Chylothorax
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Estimated Enrollment
 (submitted: September¬†20,¬†2005)
70
Original Enrollment Same as current
Actual Study Completion Date November 2006
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00215098
Other Study ID Numbers 05-093
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor Children's Healthcare of Atlanta
Collaborators Not Provided
Investigators
Principal Investigator: Brian Kogon, MD Emory University
PRS Account Children's Healthcare of Atlanta
Verification Date June 2007