Ignite Creation Date:
2024-05-05 @ 4:34 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00268099
Status:
TERMINATED
Last Update Posted:
2012-03-16
First Post:
2005-12-20
Brief Title:
Optimal Timing for Repair of Right-to-Left Shunt Lesions
Sponsor:
Childrens Healthcare of Atlanta
Organization:
Childrens Healthcare of Atlanta
Study Overview
Official Title:
Optimal Timing for Repair of Right-to-Left Shunt Lesions
Status:
TERMINATED
Status Verified Date:
2007-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
study not started
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
The secondary aim being define the criteria for failing medical therapy
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None