Optimal Timing for Repair of Right-to-Left Shunt Lesions - Full Text View

Sponsored by:	Children's Healthcare of Atlanta
Information provided by:	Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier:	NCT00268099

Purpose

The primary aim of this study is to determine the optimal timing for repair of right-to-left shunt lesions such as Tetralogy of Fallot defects.

The secondary aim being define the criteria for failing medical therapy.

Condition
Congenital Disorders

U.S. FDA Resources

Study Type:	Observational
Study Design:	Natural History, Longitudinal, Defined Population, Retrospective Study
Official Title:	Optimal Timing for Repair of Right-to-Left Shunt Lesions

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

Estimated Enrollment:	75
Estimated Study Completion Date:	November 2006

Detailed Description:

In the past, children with right-to-left shunt lesions such as Tetralogy of Fallot defects were palliated with a systemic to pulmonary artery shunt. This prevented cyanosis while the child grew to a size where complete repair could be undertaken. With the improvements in surgical technique and critical care, there is a push to do a primary complete repair for these defects at younger and younger ages. These operations should be delayed as long as possible to allow for growth but not so long that there is unnecessary cyanosis and hypoxemia.

Study Design and Methodology:

Retrospective chart review - approximately 75 patients

Preoperative data:

Diagnosis

Operative data:

Age and weight at surgery Type of surgical procedure Whether pulmonary valve is spared

Postoperative data:

Length of time on ventilator Length of time on inotropes Length of ICU stay Length of hospital stay Complications

Eligibility

Ages Eligible for Study:	up to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

patients in the congenital surgery database who have undergone reppair of a Tetralogy of Fallot defect

Exclusion Criteria:

those who do not meet inclusion criteria

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00268099

Locations

United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322

Sponsors and Collaborators

Children's Healthcare of Atlanta

Investigators

Principal Investigator:

Brian E Kogon, MD

Children's Healthcare of Atlanta

More Information

Study ID Numbers:	05-121
Study First Received:	December 20, 2005
Last Updated:	June 12, 2007
ClinicalTrials.gov Identifier:	NCT00268099
Health Authority:	United States: Food and Drug Administration

Keywords provided by Children's Healthcare of Atlanta:

pediatric
cardiac
repair of right to left shunt lesions
Tetralogy of Fallot defects

Study placed in the following topic categories:

Tetralogy of Fallot
Fallot tetralogy

ClinicalTrials.gov processed this record on January 16, 2009