Optimal Timing for Repair of Right-to-Left Shunt Lesions
|ClinicalTrials.gov Identifier: NCT00268099|
Recruitment Status : Terminated (study not started)
First Posted : December 22, 2005
Last Update Posted : March 16, 2012
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 or disease|
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
Age and weight at surgery Type of surgical procedure Whether pulmonary valve is spared
Length of time on ventilator Length of time on inotropes Length of ICU stay Length of hospital stay Complications
|Study Type :||Observational|
|Estimated Enrollment :||75 participants|
|Official Title:||Optimal Timing for Repair of Right-to-Left Shunt Lesions|
|Study Start Date :||May 2005|
|Actual Study Completion Date :||November 2006|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00268099
|United States, Georgia|
|Children's Healthcare of Atlanta|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Brian E Kogon, MD||Children's Healthcare of Atlanta|